Allogene Therapeutics (ALLO) Q3 2026 Earnings Call: Fortschritte bei ALPHA3 und Daten zu ALLO-329

Allogene Therapeutics (NASDAQ: ALLO) nutzte die Telefonkonferenz zu den Ergebnissen des dritten Quartals 2026, um die Umsetzung der ALPHA3-Studie zu cema-cel sowie die bevorstehenden Daten zu ALLO-329 bei Autoimmunerkrankungen hervorzuheben. Das Management hielt an seinem Zeitplan für die Patientenrekrutierung in der ALPHA3-Studie fest und verwies zugleich auf eine gestiegene Screening-Aktivität sowie eine stärkere Beteiligung niedergelassener Behandlungszentren.

Wichtigste Erkenntnisse

• Das Management erwartet für Mitte 2027 ein klinisches Update zu ALPHA3 und strebt weiterhin an, die Rekrutierung bis Ende 2027 abzuschließen.
• Die Rekrutierungsdynamik der ALPHA3-Studie hat sich verbessert, gestützt durch ein intensiviertes Screening auf minimale Resterkrankung (MRD), eine höhere Produktivität pro Studienzentrum sowie Aktivitäten in Korea und Australien.
• Die ALPHA3-Analyse Mitte 2027 wird einen ersten Einblick in das ereignisfreie Überleben beinhalten, dem jedoch nur ein geringes statistisches Alpha zugewiesen ist. Das Data Safety Monitoring Board könnte empfehlen, die Studie ohne Entblindung fortzusetzen.
• Allogene erklärte, cema-cel weise weiterhin ein für den ambulanten Einsatz geeignetes Sicherheitsprofil auf und werde in niedergelassenen Praxen verabreicht, darunter auch Zentren ohne vorherige CAR-T-Erfahrung.
• Für ALLO-329 berichtete das Management, dass bislang keine hochgradigen Toxizitäten oder Fälle des Immun-Effektorzell-assoziierten hämophagozytischen Syndroms (IEC-HS) aufgetreten seien.
• Die erweiterten Ergebnisse zu ALLO-329 werden zusätzliche Patienten, eine längere Nachbeobachtungszeit, drei Dosisstufen sowie drei Konditionierungsansätze umfassen: Verzicht auf Lymphodepletion, Cytoxan allein sowie Fludarabin/Cytoxan.

Geschäftliche und operative Entwicklung

ALPHA3 und cema-cel

In der ALPHA3-Studie wird cema-cel als Erstlinien-Konsolidierung bei Patienten mit MRD-positivem Lymphom untersucht. Das Management teilte mit, eine Futilitäts-Zwischenanalyse Anfang 2026 habe ermutigende Hinweise auf eine rasche MRD-Beseitigung, ein günstiges frühes Sicherheitsprofil sowie die Durchführbarkeit der Behandlung in niedergelassenen Praxen geliefert.

Nach einem zunächst verhaltenen Start infolge fragmentierter Versorgungspfade in den USA und Schwierigkeiten bei der Identifizierung von Patienten für MRD-Tests hat sich die Rekrutierung verbessert. Das Unternehmen gab an, diese operativen Hürden weitgehend behoben zu haben. Die Produktivität der Studienzentren stieg, während neu aktivierte Zentren in Korea und Australien etwa ab Mitte 2026 zügig mit dem Screening und der Rekrutierung von Patienten begannen.

Es wird weiterhin erwartet, dass Teilnehmer aus dem asiatisch-pazifischen Raum nur eine Minderheit der Gesamtrekrutierung ausmachen. Das Management rechnet nicht damit, dass der regionale Beitrag zu einem demografischen Ungleichgewicht führt, das die Bewertung durch die FDA beeinträchtigen könnte.

Allogene berichtete zudem über ein wachsendes Interesse von US-amerikanischen Praxen und plant, weitere Zentren einzubinden. Viele der teilnehmenden Ärzte verfügen bereits über Erfahrung im Umgang mit immunbedingten Toxizitäten aus bispezifischen Therapien. Die Zentren werden geschult und müssen über geeignete Medikamente verfügen, um ein Zytokin-Freisetzungssyndrom oder andere Ereignisse nach der Infusion behandeln zu können.

Das Management führte die verstärkte Screening-Aktivität auf eine breitere Anerkennung des prognostischen Werts von MRD, den zunehmenden Einsatz von MRD-Tests bei Lymphomen sowie die frühen cema-cel-Ergebnisse der Studie zurück.

ALLO-329 bei Autoimmunerkrankungen

ALLO-329 zielt sowohl auf CD19 als auch auf CD70 ab und nutzt die Dagger-Technologie von Allogene, die allogene Abstoßungsreaktionen adressieren und potenziell die Abhängigkeit von einer chemotherapiegestützten Lymphodepletion verringern soll.

Der bevorstehende erweiterte Datensatz wird Wirksamkeit und Sicherheit bei Verzicht auf Lymphodepletion, reiner Cytoxan-Konditionierung sowie Fludarabin/Cytoxan-Konditionierung vergleichen. Nach Angaben des Managements besteht das langfristige Ziel darin, ALLO-329 mit reduzierter oder gänzlich ohne Chemotherapie-Konditionierung zu verabreichen, was das Infektionsrisiko senken und die Behandlungsumgebungen erweitern könnte.

Die systemische Sklerose, insbesondere die diffuse kutane Sklerodermie, hat sich zur am weitesten fortgeschrittenen Subgruppe entwickelt, da diese Patienten schneller rekrutiert wurden. Die Basket-Studie steht weiterhin Patienten mit Lupus und Myositis offen. Zudem wurden einige Patienten mit systemischer Sklerose und interstitieller Lungenerkrankung aufgenommen.

Laut Management gilt in Fachkreisen eine Verbesserung von etwa fünf Punkten auf dem modifizierten Rodnan-Skin-Score allgemein als klinisch bedeutsam.

Breitere CAR-T-Plattform

Allogene beabsichtigt, auf der SITC klinische Erfahrungen mit ALLO-316 beim Nierenzellkarzinom sowie präklinische Ergebnisse aus seinem dualen DLL3/CD70-CAR-T-Programm vorzustellen.

Das Management argumentierte, es sei unwahrscheinlich, dass In-vivo-CAR-T-Therapien in der Erstlinien-Konsolidierung direkt mit cema-cel konkurrieren. Begründet wurde dies mit der verminderten T-Zell-Fitness der Patienten nach R-CHOP sowie den praktischen Herausforderungen bei der Verabreichung von In-vivo-CAR-T im ambulanten Umfeld niedergelassener Praxen. Hierbei handelt es sich weiterhin um die Einschätzung des Managements und nicht um eine gesicherte Marktentwicklung.

Ausblick der Unternehmensleitung

Allogene hielt an folgenden Meilensteinen für ALPHA3 fest:

• Nächstes klinisches Update: Mitte 2027.
• Angestrebter Abschluss der Patientenrekrutierung: Ende 2027.

Die Analyse des ereignisfreien Überlebens Mitte 2027 wird vom Data Safety Monitoring Board überwacht. Da für die Analyse nur ein geringes statistisches Alpha angesetzt wird, wies das Management darauf hin, dass das Gremium eine Fortsetzung der Studie ohne Entblindung empfehlen könnte. Das Unternehmen betonte, dass die Wahrung der zulassungsrelevanten Integrität von ALPHA3 oberste Priorität habe.

Risiken und Beobachtungspunkte

• Die ALPHA3-Analyse Mitte 2027 liefert möglicherweise kein öffentliches, entblindetes Wirksamkeitsergebnis, selbst wenn die zugrunde liegenden Daten ermutigend sind.
• ALPHA3 hängt von fortlaufenden MRD-Screenings, der Umsetzungsstärke der Studienzentren und der Identifizierung von Patienten innerhalb eines fragmentierten Versorgungsnetzwerks ab.
• Neue Erstlinientherapien bei Lymphomen könnten die Behandlungsergebnisse verbessern und die Therapielandschaft verändern. Allogene geht davon aus, dass Komplexität und Toxizität einer breiten Akzeptanz im Wege stehen könnten, vollständige Datensätze lagen zum Zeitpunkt der Telefonkonferenz jedoch noch nicht vor.
• ALLO-329 befindet sich weiterhin in einer frühen Phase der klinischen Entwicklung. Ein Analyst wies auf schwerwiegende unerwünschte Ereignisse bei zwei Patienten der Dosisstufe 2 hin, woraufhin das Management eine detaillierte Diskussion auf die Veröffentlichung des erweiterten Datensatzes vertagte.
• Eine chemotherapiegestützte Lymphodepletion kann die Immunkompetenz beeinträchtigen und das Infektionsrisiko erhöhen. Ob ALLO-329 bei reduzierter oder ausbleibender Konditionierung eine signifikante Wirksamkeit aufrechterhalten kann, bleibt eine zentrale klinische Frage.
• Nach dem Eintritt von Geoffrey Parker in den Ruhestand sucht das Unternehmen weiterhin nach einem neuen Finanzvorstand. Annie Yoshiyama, SVP of Finance, Corporate Controller und Principal Accounting Officer, leitet derzeit die Finanzoperationen und internen Kontrollen.

Höhepunkte der Fragen- und Antwortrunde mit Analysten

Kann cema-cel in niedergelassenen Praxen sicher angewendet werden?
Das Management äußerte großes Vertrauen in das Potenzial von cema-cel im ambulanten und niedergelassenen Bereich. Zu den ALPHA3-Studienzentren gehören auch Praxen ohne vorherige CAR-T-Erfahrung, wenngleich alle Zentren geschult werden und entsprechende Protokolle sowie Medikamente für das Toxizitätsmanagement vorhalten müssen.

Was sollten Anleger von dem ALPHA3-Update Mitte 2027 erwarten?
Die Analyse umfasst einen frühen Blick auf das ereignisfreie Überleben, doch die begrenzte Zuweisung von statistischem Alpha macht einen vorzeitigen, statistisch signifikanten Studienabbruch ungewiss. Das Data Safety Monitoring Board wird entscheiden, ob die Studie entblindet oder fortgeführt wird.

Könnten neue Erstlinien-Lymphomtherapien die Marktchancen von cema-cel schmälern?
Das Management geht davon aus, dass einige neuere Therapieschemata die Behandlungsergebnisse verbessern werden, hält es jedoch für wahrscheinlich, dass Komplexität und potenzielle Toxizität deren Einsatz auf ausgewählte Patienten und universitäre Zentren beschränken. Daher erwartet das Unternehmen derzeit keine wesentlichen Auswirkungen auf seinen angestrebten Markt für die Erstlinien-Konsolidierung.

Wie werden die ALLO-329-Daten die Effekte der CAR-T-Zellen von denen der Konditionierung trennen?
Die Präsentation wird Wirksamkeit und Sicherheit differenziert nach drei Konditionierungsstrategien und mehreren Zelldosen aufschlüsseln. Nach Angaben des Managements soll der Vergleich zeigen, ob ALLO-329 auch bei geringer oder gänzlich ohne chemotherapiegestützte Lymphodepletion Wirksamkeit entfalten kann, wenngleich die Nachbeobachtungszeiträume der Kohorten variieren.

Warum erfährt die systemische Sklerose größere Aufmerksamkeit?
Das Management erklärte, dieser Schwerpunkt spiegle das Rekrutierungsgeschehen wider und sei nicht auf eine Neuausrichtung der Studie zurückzuführen. Die diffuse kutane systemische Sklerose entwickelte sich zur größten und am weitesten fortgeschrittenen Subgruppe, während die Rekrutierung für Lupus und Myositis weiterhin offen ist.

Vollständiges Transkript der Telefonkonferenz

Vollständiges Transkript der Telefonkonferenz

Ausführungen des Managements

Operator

Hello. Thank you for standing by, and welcome to Allogene Therapeutics Third Quarter 2026 Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to turn the call over to Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer. Ms. Cassiano, please go ahead.

Christine Cassiano

Thank you, operator, and welcome, everyone, to Allogene's conference call. After the market closed, Allogene issued a press release that provided a business update and financial results for the third quarter of 2026. This press release and today's webcast are available on our website.

Following brief prepared remarks from Dr. Zachary Roberts, President and Chief Executive Officer, we will open the call for questions. Geoff Parker, Chief Financial Officer, will also join the Q&A. To keep the call within 45 minutes, please limit questions to one per analyst.

During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, the safety and efficacy of our product candidates, commercial market forecasts, the potential treatment settings and financial guidance, among other things. These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and Allogene disclaims any obligation to update these statements.

I'll now turn the call over to Zach.

Zachary Roberts

Thanks, Christine, and good afternoon, everyone. Before we begin, I want to recognize Geoff Parker, who retires tomorrow after serving as CFO through some of Allogene's most consequential years. Geoff helped us navigate change and maintain the financial discipline that positions us for the future. Geoff, thank you, and we wish you the best in retirement.

As our search for a new CFO continues, we have full confidence in our financial operations and controls under Annie Yoshiyama, our SVP of Finance, Corporate Controller and Principal Accounting Officer. Annie brings 20 years of experience and has played a key role in our financial reporting and financing activities since joining in 2024. Finding the right CFO is especially important as we enter this next chapter where the strategic decisions we've made could create meaningful new opportunities for Allogene. When I joined Allogene, my mandate was to challenge how we were developing allogeneic CAR T. We had an extraordinary technology, but technology alone wasn't enough. We needed to start with patients and work backward. What barriers prevented them from receiving CAR-T? How can an off-the-shelf product remove those barriers. CAR-T has transformed what's possible in medicine, but nearly a decade into the commercial CAR-T era, the realities of delivering CAR-T continue to limit who benefits.

We've seen other allogeneic programs stop or change course. Investor confidence in cell therapy has eroded as companies pursue highly similar strategies without overcoming the fundamental obstacles. The challenges facing the industry today are the very ones Allogene anticipated and made difficult strategic decisions to address in 2024. With our deep experience in cell therapy, we recognized that following the traditional late-line development pathway with cema-cel was unlikely to unlock the full potential of allogeneic CAR T. Meanwhile, advances in diagnostics created an opportunity to identify patients at risk of relapse before their disease returned clinically and created a compelling need for off-the-shelf CAR-T.

The real opportunity wasn't simply to develop a different kind of CAR-T, but to rethink where and when CAR-T could make the greatest difference. It gave us a chance to address a distinct area of unmet medical need, MRD-positive lymphoma and potentially change the course of treatment for patients who might otherwise face the uncertainty of relapse. We believe this strategy could make a meaningful difference for patients, and we saw it as a compelling path forward for Allogene.

We weren't simply looking for a better way to deliver CAR-T. We were looking for a better moment to use it. And that is why I believe it's time to look at Allogene through a different lens. ALPHA3 is testing whether we can fundamentally change when, where and how patients receive CAR-T.

Our interim futility analysis earlier this year provided encouraging evidence of rapid MRD clearance, a favorable early safety profile and the feasibility of administering cema-cel in community practices even at centers with no prior CAR-T experience. Enrollment momentum continues, supported by increased MRD screening, strong investigator engagement and brisk activity in the Asia Pacific region. As our trial network expands, we're seeing growing engagement across participating sites. In 2027, we look forward to our next clinical update midyear and enrollment completion by year-end.

We continue to watch the evolution of first-line lymphoma treatment closely, including the recent Phase III results with novel regimens. Better outcomes are always welcome, but safety and practical demands of treatment matter, too. Even with reimbursement, the complexity and cost of administering therapy can challenge providers. R-CHOP, along with the recently approved R-Pola-CHP regimen has been dominant for 25 years, not only because they work well, but because they are safe, well tolerated and practical to deliver in community settings. This is why we are looking beyond clinical development for challenging assumptions built around autologous CAR T from treatment site requirements to the infrastructure needed to deliver therapy.

Our view of value encompasses the total cost of care, the burden on patients and caregivers and the economics of treatment delivery. From reimbursement to site readiness, we're building a model that reflects the distinct characteristics of allogeneic CAR T and its potential to make treatment more accessible.

At ASH, we'll share findings from our survey of 152 U.S. hematologists and oncologists examining the barriers that continue to limit CAR-T adoption. We'll also host an investor event exploring how cema-cel could potentially address those barriers. That same focus on overcoming barriers extends to ALLO-329. In a few days, we'll present our first clinical results at the American College of Rheumatology Annual Meeting, or ACR. This update will offer an early glimpse into whether our deliberate choices in designing ALLO-329 and its clinical trial are translating into meaningful benefits for patients.

Safety is particularly important. Recent events across autoimmune CAR-T programs have reinforced the need to carefully balance therapeutic benefit with treatment risk. Our experience with ALLO-316 taught us difficult but important lessons about managing inflammatory toxicities, including IEC-HS. We worked closely with experts and the FDA to develop detailed monitoring and management guidance and carry those lessons directly into the resolution protocol from the outset.

To date, we have observed no high-grade toxicities or cases of IEC-HS with ALLO-329, but our approach is more than managing toxicity. ALLO-329 was designed with our Dagger technology to address allogeneic rejection with the potential to reduce reliance on chemotherapy-based lymphodepletion. That's particularly important in autoimmune disease where balancing benefit toxicity and treatment burden is critical.

On November 9, we'll present an expanded clinical and translational data set at AACR, including additional patients, longer follow-up, three dose levels and three conditioning approaches. We'll be looking closely at what the data tell us about CAR-T activity and clinical responses across different conditioning approaches. One of the most important questions is whether DaggR can help us achieve meaningful activity while reducing the chemotherapy burden traditionally associated with CAR-T. That's a potentially important distinction, particularly in autoimmune disease.

We're very interested in what we're seeing in scleroderma, which has emerged as the most active pathway to enrollment in our basket design. While patients with lupus or myositis remain eligible for resolution, we're becoming more deliberate about prioritizing indications where ALLO-329 could offer the greatest differentiation. The lessons we're learning across these programs are also informing the next generation of our platform. That work will be featured at SITC, including our clinical experience with ALLO-316 in renal cell carcinoma and preclinical findings from our DLL3/CD70 dual CAR-T program. Across our programs, we've made deliberate choices, applied what we've learned and invested in a different model for CAR-T. In a field driven by the next breakthrough, we know that innovation is only the beginning. The real achievement is making it work in the real world. That's what we've spent years building towards. And as we look into 2027, we believe our clinical data could begin to demonstrate the value of those decisions.

What comes next has the potential to be far more exciting than the science that first captured everyone's imagination because innovation only matters if patients can access it.

We'll now open the call for questions.

Operator

[Operator Instructions] Our first question is from Tyler Van Buren with TD Cowen.

Fragen und Antworten

Tyler Van Buren

Can you just discuss your ongoing confidence, again, in administering cema-cel in the outpatient setting and at community practices, especially those with no prior CAR-T experience. You discussed this a little bit during the prepared remarks, but it would be great to elaborate on that and how you teach and educate them to adopt the appropriate protocols and patient monitoring.

Zachary Roberts

Tyler, thanks for the question. So our confidence is very high that this is an outpatient-friendly and community-ready product, and we are actively continuing to screen and treat patients in such settings within the ALPHA3 trial. And by the way, we've had kind of a significant surge in interest from community practices over the course of the summer. So we're actually preparing to onboard additional community practices in the coming weeks here.

As far as preparing them to do this, many of them will have bispecifics, maybe all of them have bispecifics experience. So they're familiar with the potential toxicities associated with immune-directed therapies. So they're not coming in completely cold. Some of them don't have any CAR-T experience, though. And so us being able to do that successfully and safely, I think, really illustrates the opportunity that we face with cema-cel and ALPHA3.

That said, of course, we take nothing for granted and all sites are adequately trained. We ensure that they have the right medications available should they need to intervene for CRS or some other event that occurs post cema-cel infusion. But so far, the safety profile continues to be very, very good and really supporting our view that this is a great new way to access CAR-T for patients, including in their community practices.

Operator

Our next question comes from Michael Yee with UBS.

Michael Yee

Congrats on the progress. I'll save the autoimmune questions for next week. But on ALPHA3, can you just update or clarify your thoughts around the mid-'27 update? And remind us about how you feel about the enrollment pace relative to, say, 6 or 12 months ago, the event rates you're seeing blinded, of course. And then even though you have a very small alpha spend, as I think you've said, your view about whether it would actually stop unblind or if it could continue and just walk through some of the assumptions that are in there because you have said it's going to -- it's a very small alpha spend. So I want to be a bit cautious about whether we should over expect a positive stop.

Zachary Roberts

Thanks, Mike. So great questions. So I'll take the enrollment piece first. As we pointed out in the prepared remarks, we're very pleased with where the study is headed and how it's been performing, particularly in the last several months, not just with the renewed interest and new incoming interest from additional sites, but even per site productivity has notched upward and that applies broadly, but particularly as Korea and Australia have begun to screen and enroll since about mid-summer. They really have really come into this trial with a high degree of interest and engagement and are screening lots of patients, and we've seen enrollment come from both of those regions very quickly after those first sites were activated. So we continue that to be very positive.

So as far as the enrollment goes, I mean, we're continuing to guide towards the end of next year. Your question around event rates and the timing and nature of the mid-2027 data update. As we have said in response to this question, lots of times, this study is governed by a Data Safety Monitoring Board as well as, of course, the FDA is involved in how we execute and read out this trial. You also rightly reminded everyone that there's a small amount of alpha that's currently allocated to that mid-'27 early look at the primary endpoint event-free survival.

So the nature of the question, I think, is completely a and that is what are we thinking that this is going to be a positive study that is statistically significant, I mean positive readout. And what will we do in that case? Of course, this is going to be governed by the Data Safety Monitoring Board, who is going to perform this analysis. And of course, they may, given the small amount of alpha, look at the data and decide that, in fact, the recommendation is to not unblind the data and continue moving forward. Of course, we don't really have a strong opinion about whether that's likely or not. We were very encouraged about the interim futility analysis that we discussed earlier this year.

But that, again, is going to be up to the statistical design of the study and the recommendation of the Data Safety Monitoring Board. So first and foremost, we're going to follow their guidance. But again, in the big picture, the most important thing that we do here on this trial is to not do anything that would jeopardize the overall registrational quality of this study. And so the risk to trial integrity of premature disclosure of interim data is something that we take very seriously. And so we will be sort of approaching this analysis with that in mind. But in any case, our #1, 2 and 3 priorities right now are just executing on the trial, getting the trial completely enrolled by the end of next year.

Operator

Our next question comes from Roger Song with Jefferies.

Jiale Song

Recently, we saw the EPOCH-R R-CHOP data in the first line, understanding your position or on. Just curious, any recent feedback from the community, now we see the hazard ratio or the efficacy concretely. Any thoughts around the potential new standard of care in the first line? And then how should we think about the MRD negative in this new regimen moving forward?

Zachary Roberts

Thanks, Roger. Great question. Of course, we've been watching the frontline area quite closely. And I'll remind everybody that we did see a readout earlier this summer as well with tafasitamab lenalidomide plus R-CHOP that read out at ASCO. So there's a couple of data sets that we're paying attention to. I think the hazard ratio that you cite a little bit under 0.5, I think, was a little bit better than a lot of folks had anticipated. I will point out that that's the only thing that we know about the data so far. There was no -- notably, there was not a mention of the frontline EPOCH-R data in the batch of ASH abstracts that came out yesterday, but potentially it could be a late breaker. So we'll be watching that carefully.

I think what we've said about these regimens applies again, and that is that these are potentially going to improve outcomes and that I think would generally be a good thing for patients. However, the feedback that we have gotten from sites, both anecdotally, but also through the data, the analysis that I referenced in the prepared remarks around the abstract that we'll show at ASH regarding 152 oncologists spread across both community and academic contexts. The feedback that we've received on these frontline regimens is that they're not likely to be widely applied to all newly diagnosed patients, primarily due to the complexity and the possible toxicity of these regimens.

Again, we don't really know the full data from the front line. We do know some data from the later line studies, and they do appear to have a toxicity burden that is significantly higher than R-CHOP. So we'll be watching the eventual data update. But in the final analysis, given the fact that we think that these will be for limited patients and limited academic centers, we do not expect this to be a major impact to our total addressable market in the frontline consolidation context where, of course, we're focused with cema-cel.

Operator

Our next question comes from Salveen Richter with Goldman Sachs.

Unknown Analyst

This is Mark on for Salveen. So excited to see the ALLO-329 data, and we're looking forward to the additional data at ACR in the event. Our question is on safety, as you alluded to, we see that there's two patients in DL2 that experienced serious AEs, understanding these are small numbers, but can you speak to your confidence in the safety profile and the management protocols as you continue dose escalation? Could these infections be driven by the CD70 mechanism? And do you expect that there could be potentially different safety profiles for the with and without lymphodepletion cohorts?

Zachary Roberts

Mark, thanks for the question. I mean I'll save some of the detailed response to the data until after it's been disclosed in full, which we expect will be on Monday next week. In general, I think your question around does lymphodepletion potentially impact the safety profile. I think in general, that is likely to be true. We know that fludarabine and cytoxan when given together do tend to drive patients' immunity immunocompetence, I should say, down pretty low for a period of time, and that's kind of its point when used in this context. So lightening up or eliminating altogether that cytotoxic lymphodepletion regimen is absolutely a goal of ours to try to prevent exposing these patients to unnecessary infectious risk.

As far as the SAEs that you go, again, I'm going to -- I'll hold back on kind of diving into what the specific nature of those are. The data will be out in just a few days. I'll say, in general, though, we have not seen anything concerning so far across CRS, ICANS, even infections. So stay tuned for the final -- the results that you referred to. But so far, we're pretty confident about the safety profile that we're seeing with ALLO-329.

Operator

Our next question comes from Samantha Semenkow with Citi.

Samantha Semenkow

Just another one on cema-cel. Can you speak to the increase in MRD screening that you're seeing? What is driving this? Is it the broader adoption for MRD testing in general that we're seeing across multiple oncology settings? Or is it more of a result of the educational efforts that you've instilled or just the overall increase in interest in the trial?

Zachary Roberts

Sam, thank you, as always, for the question. And I think it's probably a combination of all those things and potentially others. I think, as we've said before, when we launched ALPHA3, we were really out in front on this and saw the field shaping up and a growing reliance on MRD as a general concept across all oncology indications, but particularly within lymphoma based on those early data that were presented at ASH in 2022.

That theme has continued to grow in leaps and bounds really. And I think that the earlier approval by FDA of atezolizumab when paired with the Signatera results in muscle invasive bladder cancer, I think, really put quite a bit of fuel on this fire and people began to realize that the prognostic power of an MRD result could be used to guide clinical decision-making. And so that's become more widely expected and more widely understood, I should say. And so we're seeing some benefits of that within lymphoma, and we're seeing even commercial sales of MRD tests within lymphoma spiking quarter-over-quarter. That growth has continued. So as that begins to occur outside of the ALPHA3, looking into the ALPHA3 trial itself, of course, people were encouraged by the early data that we showed. They are becoming believers in MRD. They see the data with cema-cel. So suddenly, we have a lot of these pieces that we knew to exist from day 1 starting to fall into place just as we're hitting our stride with more sites coming online a global expansion of the trial footprint. So we really are the beneficiaries of a lot of these moving parts, all starting to lead to better screening and enrollment cadence within the trial. So we overall see this as quite a positive development across the field.

Operator

Our next question comes from Matthew Phipps with William Blair.

Matthew Phipps

Look forward to the call on Monday. The press release mentions brisk enrollment in Asia Pacific regions. Just curious, what's your expectations for final enrollment percentage coming from Asia Pacific? And is there any kind of caps on that enrollment to maintain balanced demographics?

Zachary Roberts

Thanks, Matt. So yes, as I said a moment ago in the prepared remarks, of course, we're pretty encouraged with the level of engagement that we're seeing from the investigators in Australia and in Korea. In large part, that's due to how care is delivered there. There -- a lot of these patients are all seen in the same large centers. So the throughput is really quite, quite impressive there, especially compared to a standard U.S. site. So we're leveraging that concentration of care there.

Even at the pace -- the impressive pace that they're screening and enrolling, they still are expected to be a relative minority of the overall enrollment within ALPHA3. And so we're not concerned about any kind of imbalance that may impact the interpretability by FDA. That's not a concern of ours at all. And we're seeing great activity by U.S.-based sites as well.

Operator

Our next question comes from the line of Jack Allen with Baird.

Jack Allen

Congrats on the progress. I wanted to ask a bigger picture one about the landscape in non-Hodgkin's lymphoma. I know you commented earlier on the bispecifics and the EPOCH-R data, but I also wanted to ask if you had any thoughts on recent updates from the in vivo CAR-T space. I know people are watching durability closely there, and I think there have been a few different updates and we'll probably get some more data at ASH. So just wanted to gauge your opinions there.

And then I just want to take a brief second to thank Geoff as well and congratulate him on his retirement. Geoff, it's a key career milestone I'm looking forward to keeping in touch.

Geoffrey Parker

Thank you, Jack. Appreciate it.

Zachary Roberts

Thanks, Jack, for the question. So yes, I mean, I think the frontline landscape is evolving, and we'll see how that shakes out in the coming months and years. As far as the in vivo space goes, we've seen a few very early data sets in lymphoma. I'm thinking about the uptick that we saw at EHA earlier this year with the 1920. That was very limited follow-up. But of course, we've seen evidence of activity in other oncology contexts with in vivo CAR-T.

I'll say, in general, I do not believe that in vivo CAR-T is going to be applicable in the consolidation context as we're doing with ALPHA3. I really do believe that our product profile is uniquely well suited for frontline consolidation for a few reasons. First, these patients are relatively lymphodepleted post frontline R-CHOP. And the sooner you deliver your consolidation dose, the more lymphodepleted they are, they haven't quite recovered. So administering a CAR-T to those patients and in vivo CAR-T that relies on healthy and robust and high-frequency T cells is going to be somewhat limited.

The other big one, of course, is these patients tend to be treated in the community, and it's very hard for me to see having taken care of patients, but also based on the feedback we are hearing from community practitioners, it's just not likely that an in vivo CAR-T is going to be administered in an outpatient community-based oncology practice. That's just -- that's an academic a therapy that's well suited for academia. So my view is that if in vivo does demonstrate great activity and durability, perhaps it could be something that challenges the current areas where autologous CAR-T are used because I do think it brings some benefit over autologous CAR T. But I do not think that it's ever really going to make inroads into the frontline consolidation context.

So this is something that we're, of course, very interested in watching this field develop. But we think that based on the product profile alone, the toxicity profile, the complexity, et cetera, the limitations around location where it can be administered that this is not likely to erode much of our opportunity within the frontline consolidation.

Operator

Our next question comes from the line of John Newman with Canaccord Genuity.

John Newman

I'd like to add my congratulations to Geoff as well, very solid work here at Allogene over time. My question is, I wanted to know if the pace of enrollment has been in line or perhaps exceeded your expectations over time for ALPHA3. And how we should think about that with regard to the upcoming interim look for EFS in mid-'27.

Zachary Roberts

John, so I think we've talked about this in the past. I mean, right now, the study is in a great place, full stop. It's for all the reasons that I've already said, which I won't repeat. In the early days, it did take some understanding of how to implement this trial. And the fragmentation of care within the United States, some of the difficulties in finding the patients to do MRD testing for, that really was a little bit of a slow start. And so we did adjust the time line, the expectations early on in the course of the study.

We haven't done that again, and that's for a very good reason is that we largely have figured out those operational challenges. So our guidance is our guidance. We do think that we're on track for a completion of the study by the end of next year. And I've already commented on kind of the timing of that midyear update, and that's something that at this point, we don't see any reason to change that guidance.

Operator

Our next question comes from the line of Biren Amin with Piper Sandler.

Unknown Analyst

This is Michael. We were wondering for resolution, what degree of skin improvement would you describe as clinically meaningful on MRSS? And do you plan on enrolling any scleroderma patients with ILD.

Zachary Roberts

Thanks, Michael. So when we say clinically significant, that is -- there is a sort of a widely accepted threshold for improvement in the skin score, which you rightly identify as the modified Rodnan Skin Score or MRSS. And that is about a 5-point change in the MRSS score. So this is -- when we say clinically significant, we really are referring to something that is accepted generally within the field, not something that we're just sort of calling out on our own. So -- that's the first question.

The second question is you asked about ILD. So we have had some patients enrolled with interstitial lung disease with the systemic sclerosis diagnosis. We've also had some myositis patients and some lupus patients. And as we point out, the focus of this upcoming presentation is on scleroderma with skin predominance or diffuse cutaneous systemic sclerosis. That happens to be the group of patients who has enrolled in the study most commonly to date. So we actually have a nice group of patients that we're excited to share our efficacy data on. The remaining patients will be a focus of future updates as those data mature and we get a few more patients with each of those diagnoses.

Operator

Our next question comes from the line of Brian Cheng with JPMorgan.

Lut Ming Cheng

You mentioned that there is a deliberate focus for 329 on scleroderma in the ongoing Phase I. What does that mean for the path forward for myositis and lupus? And just to confirm, is that decision -- is that deliberate tilt purely based on efficacy?

Zachary Roberts

Thanks, Brian, for the question. So the -- when we started activating sites, we, of course, have sites who are famous for their central role in the management of patients with cutaneous scleroderma. We've got some that are known for their expertise in lupus and others in myositis. It just so happened that the ones who came on and who have patients available in the early days of the study tended to be those diffuse cutaneous scleroderma patients. And so this was a natural outgrowth of our basket design. This wasn't anything that we did deliberately.

However, I will say that some of the enthusiasm that grew continuously over the enrollment period largely came from those docs who were taking care of patients with the cutaneous scleroderma. And so it became a little bit of a virtuous cycle where more patients with that diagnosis ended up coming in. However, the study is still open for patients with myositis and lupus, and we do see some continued interest actually from sites and from patients with those diagnoses. So we haven't closed the study. We haven't changed the design of the trial at all. We're really just sharing kind of the most mature subgroup that we have collected so far.

Operator

Our next question comes from the line of Robert Burns with H.C. Wainwright.

Robert Burns

So focusing on that upcoming data for ALLO-329, how are you thinking about the go/no-go signal for this agent in the autoimmune context broadly, but also within systemic sclerosis, especially when we consider the allogeneic CAR T data that we've seen from azer-cel as well as the upcoming data updates at ACR for FT819, CTA313, zugo-cel as well as several in vivo CAR-T agents.

Zachary Roberts

Thanks, Robert. Look, we knew from the beginning that this was a busy space. And so our response to that was to design a product that was differentiated that brought something new and novel to the table. And so we believe very fervently that ALLO-329 does just that. We're the only product that hits both CD19 and CD70. Of course, the role of CD19 is well described, but CD70 is -- continues to impress me at just how widely it's described as playing a role in inflammatory processes. And I feel like every month, there's a new paper coming out showing that how central it is to the behavior of lymphocytes, both T and B lymphocytes in the pathogenesis of these and other indications. So we remain extremely excited about our differentiated product profile here. And so we think we're going to have something of value. Additionally, in our trial design, of course, we set out to design a product that would alleviate the need for chemotherapy-based lymphodepletion.

So as you all are reviewing the data when it is public on Monday, I encourage you to take a look at whether we're delivering on that initial intent and promise. So we think that we have something quite exciting here, and we're looking forward to sharing the data on Monday.

As far as the go/no-go, and, of course, we're still in early days. I mean we just opened the trial a little under a year ago. We're very, very impressed at how quickly we've been able to enroll the study. So we are going to be making those go/no-go decisions internally based on some of which you'll see on Monday, but of course, other analyses as well. So stay tuned for future decisions on this product. But so far, I think we're in a really good place.

Operator

And our last question comes from the line of Luca Issi with RBC Capital Markets.

Unknown Analyst

This is [ Cassie ] for Luca. Congrats on the quarter and Geoff for all the accomplishments with the rest of the Allogene team. I have a two-part question on the resolution trial for 329. As we look forward to the expanded data, your presentation next week, if you could just help us prepare for what is coming. And Zach already touched on some of this. So first on the efficacy side, could you speak to how the trial design would serve to distinguish the contribution of 329 from chemo-based conditioning? And as we look at the data across the arms, what specific readouts will be helpful to parse out the ALLO-329's contribution from the conditioning regimen? And on the safety side, what thresholds or patents would be sufficient to support advancing no lymphodepletion or reduced lymphodepletion regimen into Phase II?

Zachary Roberts

Thanks, Cassie. So when we designed the trial, we wanted to -- again, I sort of just spoke on what our vision was for the ultimate future of ALLO-329, right? In a perfect world, we're able to do administer this product without any preconditioning at all. We believe that, that will open doors to greater numbers of patients, potentially greater sets of indications and critically greater venues for treatment, including potentially even outpatient community just like we're doing with cema-cel. So that's our vision.

As far as the efficacy and safety breakdown that you alluded to in your question, we've tried to organize the data in the presentation that will clearly show you what the contributions of ALLO-329 are compared to the contributions of the chemotherapy-based lymphodepletion regimens. And I'll say again that we will see data with no lymphodepletion data with cytoxan alone as well as data with Flu/Cy. It's not going to be the same across all three because the different cohorts were opened at different points. And then we'll have also multiple cell doses as well.

So you'll see all this data broken down on the efficacy side as well as the safety side. And as I said, we're encouraged by what we've seen so far and remain focused on that potential to do this with low or no lymphodepletion in a way that is safe for patients and easy to administer. So we think we have something that is truly differentiated here.

Operator

Thank you. And that concludes our question-and-answer session. Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program, and you may now disconnect.