알로진 테라퓨틱스(ALLO) 2026년 3분기 실적 발표 콘퍼런스 콜: ALPHA3 진행 상황 및 ALLO-329 데이터

알로진 테라퓨틱스(NASDAQ: ALLO)는 2026년 3분기 실적 발표 콘퍼런스콜을 통해 ALPHA3 세마셀(cema-cel) 임상시험의 순조로운 진행과 다가오는 ALLO-329 자가면역질환 데이터 발표를 강조했다. 경영진은 스크리닝 활동 증가와 지역사회 의료기관 참여 확대를 강조하는 한편, 기존의 ALPHA3 환자 등록 일정을 유지했다.

주요 핵심 내용

• 경영진은 2027년 중반에 ALPHA3 임상 데이터를 업데이트할 수 있을 것으로 예상하며, 2027년 말까지 환자 등록을 완료한다는 목표를 유지하고 있다.
• 미세잔존질환(MRD) 스크리닝 증가, 기관별 환자 등록 효율 개선, 한국 및 호주에서의 활발한 참여에 힘입어 ALPHA3 환자 등록 모멘텀이 강화되었다.
• 2027년 중반에 진행될 ALPHA3 분석에는 무사건생존율(EFS) 초기 데이터가 포함될 예정이나, 배정된 통계적 유의수준(알파)은 소량에 불과하다. 이에 따라 데이터안전성모니터링위원회(DSMB)가 맹검을 해제하지 않고 임상을 계속 진행하도록 권고할 수 있다.
• 알로진은 세마셀이 외래 치료에 적합한 안전성 프로파일을 지속적으로 보여주고 있으며, 이전 CAR-T 치료 경험이 없는 센터를 포함한 지역사회 병·의원에서 투여되고 있다고 밝혔다.
• ALLO-329와 관련해 경영진은 현재까지 고등급 독성이나 면역작용세포 관련 혈구탐식증후군(IEC-HS) 사례는 보고되지 않았다고 밝혔다.
• 확장 발표될 ALLO-329 결과에는 추가 환자군, 더 긴 추적 관찰 기간, 3개 용량군, 그리고 림프구 고갈 없음, 사이톡산 단독, 플루다라빈/사이톡산 병용 등 3가지 전처치 방식이 포함될 예정이다.

사업 및 운영 실적

ALPHA3 및 세마셀

ALPHA3는 미세잔존질환(MRD) 양성 림프종 환자를 대상으로 세마셀의 1차 공고요법 효과를 평가하고 있다. 경영진은 2026년 초 실시된 중간 무용성 평가에서 신속한 MRD 제거, 양호한 초기 안전성, 지역사회 병·의원에서의 치료 실현 가능성 등 고무적인 근거가 확인되었다고 전했다.

미국의 파편화된 진료 체계와 MRD 검사 대상 환자 식별의 어려움으로 인해 초기 환자 등록은 다소 더뎠으나 이후 개선되었다. 회사는 이러한 운영상의 문제를 대부분 해결했다고 밝혔다. 임상 기관의 생산성이 향상되었으며, 한국과 호주에서 새롭게 가동된 센터들이 2026년 중반부터 환자 스크리닝과 등록을 빠르게 진행하기 시작했다.

아시아·태평양 지역 환자는 여전히 전체 등록 환자 중 소수를 차지할 것으로 예상된다. 경영진은 이 지역 환자 비중이 미 식품의약국(FDA)의 데이터 해석에 영향을 미칠 정도의 인구통계학적 불균형을 초래하지는 않을 것으로 보고 있다.

알로진은 또한 미국 지역사회 병·의원들의 관심이 높아지고 있으며 참여 기관을 추가로 확보할 계획이라고 밝혔다. 다수의 참여 의료진은 이미 이중특이항체 치료제를 통한 면역 관련 독성 관리 경험을 보유하고 있다. 각 기관은 사전 교육을 받으며, 사이토카인 방출 증후군이나 기타 투여 후 이상반응을 관리하기 위한 적절한 치료제를 갖추어야 한다.

경영진은 스크리닝 활동이 활발해진 원인으로 MRD의 예후적 가치에 대한 광범위한 인식, 림프종 치료에서 MRD 검사의 활용 확대, 그리고 이번 임상에서 나타난 세마셀의 초기 결과 등을 꼽았다.

자가면역질환 대상 ALLO-329

ALLO-329는 CD19와 CD70을 동시에 표적으로 하며, 동종 거부반응을 해결하고 화학요법 기반 림프구 고갈에 대한 의존도를 잠재적으로 줄이도록 설계된 알로진의 대거(Dagger) 기술이 적용되었다.

향후 발표될 확장 데이터셋에서는 림프구 고갈 없음, 사이톡산 단독 전처치, 플루다라빈/사이톡산 전처치 간의 효능과 안전성을 비교할 예정이다. 경영진은 장기적 목표가 화학요법 전처치를 축소하거나 배제한 채 ALLO-329를 투여하는 것이며, 이를 통해 감염 위험을 낮추고 치료를 시행할 수 있는 의료 환경을 넓힐 수 있을 것이라고 밝혔다.

전신경화증, 특히 미만성 피부형 전신경화증의 경우 환자 등록이 더 신속하게 진행되어 가장 데이터가 성숙한 하위 그룹으로 자리 잡았다. 이번 바스켓 임상은 루푸스 및 근염 환자에게도 계속 열려 있다. 간질성 폐질환을 동반한 일부 전신경화증 환자도 등록을 마쳤다.

경영진은 수정 로드난 피부 점수(mRSS)에서 약 5점의 개선이 나타날 경우 해당 분야에서 일반적으로 임상적 의미가 있는 것으로 평가된다고 설명했다.

광범위한 CAR-T 플랫폼

알로진은 미국면역항암학회(SITC)에서 신세포암 대상 ALLO-316의 임상 경험과 DLL3/CD70 이중 CAR-T 프로그램의 전임상 연구 결과를 발표할 계획이다.

경영진은 인비보(in vivo) CAR-T가 1차 공고요법 분야에서 세마셀과 직접 경쟁할 가능성은 낮다고 주장했다. R-CHOP 요법 이후 환자의 T세포 적합성(fitness)이 저하된다는 점과 지역사회 외래 진료 환경에서 인비보 CAR-T를 투여하는 데 따르는 현실적인 어려움이 주된 근거였다. 다만 이는 확정된 시장 결과라기보다는 경영진의 자체적인 평가다.

경영진 가이던스

알로진은 다음과 같은 ALPHA3 주요 목표 일정을 유지했다.

• 차기 임상 데이터 업데이트: 2027년 중반.
• 환자 등록 완료 목표: 2027년 말.

2027년 중반에 진행될 무사건생존율 분석은 데이터안전성모니터링위원회가 감독한다. 해당 분석에 배정된 통계적 유의수준(알파)이 소량에 불과하기 때문에 경영진은 위원회가 맹검을 해제하지 않고 연구를 계속 진행하도록 권고할 수 있다고 주의를 당부했다. 회사는 ALPHA3의 허가 임상으로서의 무결성을 지키는 것이 최우선 과제라고 밝혔다.

리스크 및 주요 점검 사항

• 기저 데이터가 고무적이라 할지라도 2027년 중반 ALPHA3 분석에서 대외적으로 공개되는 맹검 해제 유효성 결과가 나오지 않을 수 있다.
• ALPHA3의 성공 여부는 파편화된 의료 전달 체계 전반에서의 지속적인 MRD 스크리닝, 임상 기관의 실행력, 그리고 환자 발굴에 달려 있다.
• 새로운 1차 림프종 요법들이 치료 성과를 개선하며 치료 환경에 변화를 줄 수 있다. 알로진은 복잡성과 독성으로 인해 이러한 요법들의 광범위한 도입이 제한될 수 있다고 보고 있으나, 콘퍼런스콜 당시에는 전체 데이터가 아직 공개되지 않은 상태였다.
• ALLO-329는 아직 초기 임상 개발 단계에 머물러 있다. 한 애널리스트가 용량 레벨 2 환자 2명에게서 발생한 중대한 이상반응을 지적했으나, 경영진은 확장 데이터 발표 시점까지 구체적인 논의를 유보했다.
• 화학요법 기반 림프구 고갈은 면역 기능을 억제하고 감염 위험을 증가시킬 수 있다. 전처치를 축소하거나 생략하더라도 ALLO-329가 유의미한 활성을 유지할 수 있을지가 핵심적인 임상적 과제로 남아 있다.
• 회사는 제프리 파커(Geoffrey Parker)의 은퇴 이후 후임 최고재무책임자(CFO)를 계속 물색하고 있다. 현재 재무 담당 수석 부사장(SVP)이자 기업 컨트롤러 겸 최고회계책임자인 애니 요시야마(Annie Yoshiyama)가 재무 운영 및 관리를 총괄하고 있다.

애널리스트 Q&A 주요 내용

세마셀을 지역사회 병·의원에서 안전하게 투여할 수 있는가?
경영진은 세마셀의 외래 진료 및 지역사회 병·의원 활용 잠재력에 대해 강한 자신감을 표명했다. ALPHA3 임상 기관에는 기존 CAR-T 치료 경험이 없는 병·의원도 포함되어 있지만, 모든 센터는 사전 교육을 받으며 적절한 독성 관리 프로토콜과 치료제를 갖추어야 한다.

투자자들은 2027년 중반 ALPHA3 업데이트에서 무엇을 기대해야 하는가?
이번 분석에는 무사건생존율 초기 데이터가 포함되지만, 통계적 유의수준(알파) 배정이 제한적이어서 통계적으로 유의미한 조기 중단 여부는 불확실하다. 데이터안전성모니터링위원회가 맹검을 해제할지 아니면 시험을 계속 진행할지를 결정하게 된다.

새로운 1차 림프종 요법으로 인해 세마셀의 기회가 축소될 수 있는가?
경영진은 일부 새로운 요법이 치료 결과를 개선할 것으로 기대하면서도, 복잡성과 잠재적 독성으로 인해 선별된 환자와 대형 병원 중심으로 사용이 제한될 수 있다고 보고 있다. 따라서 회사는 현재 목표로 하는 1차 공고요법 시장에 큰 타격은 없을 것으로 예상하고 있다.

ALLO-329 데이터에서 CAR-T의 효과와 전처치의 효과를 어떻게 구분할 것인가?
이번 발표에서는 세 가지 전처치 전략과 여러 세포 용량에 따른 효능 및 안전성을 세분화해 공개할 예정이다. 코호트별 추적 관찰 기간에 차이가 있기는 하지만, 경영진은 화학요법 기반 림프구 고갈을 낮추거나 배제한 상태에서도 ALLO-329가 활성을 나타낼 수 있는지를 보여주기 위해 이번 비교 연구가 설계되었다고 설명했다.

전신경화증이 더 큰 주목을 받는 이유는 무엇인가?
경영진은 이러한 관심이 임상 설계 변경이 아닌 환자 등록 추이를 반영한 결과라고 밝혔다. 미만성 피부형 전신경화증 환자군이 가장 규모가 크고 데이터가 성숙한 하위 그룹이 되었으며, 루푸스와 근염 환자 등록도 계속 진행 중이다.

실적 발표 콘퍼런스콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

질의응답

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.