Cuộc họp công bố kết quả kinh doanh Q2 2026 của ADC Therapeutics (ADCT): Mối quan ngại của FDA về LOTIS-5, 219,1 triệu USD tiền mặt

Thông tin trọng tâm

• Doanh thu sản phẩm ròng của ZYNLONTA đạt 18,6 triệu USD trong quý 2 năm 2026, so với 18,1 triệu USD trong quý 2 năm 2025. Ban lãnh đạo cho biết sản lượng bán hàng vẫn duy trì ổn định so với các quý gần đây.
• Thử nghiệm lâm sàng Pha III LOTIS-5 đã đạt tiêu chí đánh giá chính về thời gian sống thêm không bệnh tiến triển, nhưng FDA đã đưa ra những lo ngại đáng kể về tỷ lệ lợi ích - rủi ro và việc xác minh lợi ích lâm sàng. ADC Therapeutics đang đánh giá dữ liệu bổ sung, các biện pháp quản lý rủi ro và khả năng sửa đổi nhãn sản phẩm.
• LOTIS-7 đã hoàn thành việc chiêu mộ 100 bệnh nhân ở mức liều 150 microgram/kg ZYNLONTA kết hợp với glofitamab. Công ty đã nộp dữ liệu cho ASH và có kế hoạch xin cấp chứng nhận liệu pháp đột phá vào năm 2026.
• Lỗ ròng theo GAAP trong quý 2 đã thu hẹp xuống còn 16,6 triệu USD từ mức 56,6 triệu USD của cùng kỳ năm trước. Lỗ ròng đã điều chỉnh giảm xuống 16,3 triệu USD từ 28,7 triệu USD, chủ yếu do chi phí hoạt động giảm.
• Tiền và các khoản tương đương tiền đạt tổng cộng 219,1 triệu USD vào cuối quý. Ban lãnh đạo dự kiến nguồn tiền mặt hiện có đủ khả năng duy trì hoạt động ít nhất đến năm 2028.
• Một cuộc tái cấu trúc chiến lược đã giảm khoảng 17% lực lượng lao động và dự kiến sẽ tiết kiệm được khoảng 10 triệu USD chi phí hàng năm.

Dữ liệu tài chính quan trọng

Trong 6 tháng đầu năm 2026, giá vốn bán hàng sản phẩm là 6,0 triệu USD, so với 2,9 triệu USD trong cùng kỳ năm 2025.

Kết quả kinh doanh và hoạt động

ZYNLONTA tiếp tục được định vị là liệu pháp đơn trị liệu cho bệnh u lympho tế bào B lớn khuếch tán từ phác đồ bước ba trở đi. Kể từ khi nhận được phê duyệt cấp tốc từ FDA vào năm 2021, liệu pháp này đã được sử dụng để điều trị cho khoảng 5.000 bệnh nhân tại Mỹ.

Ban lãnh đạo cho biết việc công bố thông tin về LOTIS-5 không ảnh hưởng đến số lượng bệnh nhân hoặc hành vi kê đơn của bác sĩ đối với chỉ định đã được phê duyệt hiện tại. Công ty cũng tuyên bố rằng phản hồi của FDA tại cuộc họp pre-sBLA liên quan cụ thể đến phác đồ kết hợp ZYNLONTA với rituximab, chứ không phải đơn trị liệu ZYNLONTA.

LOTIS-7 đang đánh giá ZYNLONTA kết hợp với glofitamab ở bệnh nhân DLBCL từ phác đồ bước hai trở đi. Số lượng bệnh nhân đăng ký tham gia đã đạt 100 người ở mức liều được chọn. ADC Therapeutics cho biết hồ sơ nộp cho ASH chứa dữ liệu từ đại đa số bệnh nhân đã tham gia và tiếp tục mô tả các kết quả về hiệu quả và độ an toàn là rất thuyết phục. Công ty cũng đang đánh giá thiết kế cho thử nghiệm Pha III.

Đối với u lympho tiến triển chậm, dữ liệu cập nhật về u lympho vùng rìa (MZL) đã được nộp cho ASH. ADC Therapeutics dự kiến sẽ xin cấp chứng nhận liệu pháp đột phá cho MZL. Dữ liệu cập nhật về u lympho thể nang dự kiến sẽ có vào quý 2 năm 2027.

Dự báo của Ban lãnh đạo

Ban lãnh đạo dự kiến đợt tái cấu trúc tháng 6 sẽ mang lại khoản tiết kiệm khoảng 10 triệu USD hàng năm. Kết hợp với số dư tiền mặt 219,1 triệu USD vào cuối quý, công ty dự kiến khả năng duy trì dòng tiền mặt sẽ kéo dài ít nhất đến năm 2028.

ADC Therapeutics có kế hoạch nộp yêu cầu cấp chứng nhận liệu pháp đột phá cho liệu pháp kết hợp ZYNLONTA-glofitamab vào năm 2026. Việc xuất bản và nộp hồ sơ đưa vào dược thư tiềm năng cho LOTIS-5, LOTIS-7 và MZL dự kiến sẽ diễn ra sau các buổi trình bày dữ liệu theo kế hoạch, với khả năng được đưa vào dược thư bắt đầu từ năm 2027.

Ban lãnh đạo cho biết họ dự kiến có những cơ hội để tăng trưởng ZYNLONTA bắt đầu từ năm 2027, tùy thuộc vào tiến trình lâm sàng, quy định quản lý và dược thư.

Rủi ro và các điểm cần theo dõi

Yếu tố không chắc chắn chính về mặt pháp lý là hướng đi tiếp theo cho LOTIS-5. Mặc dù nghiên cứu đã đạt tiêu chí đánh giá chính, FDA đã bày tỏ sự lo ngại đáng kể về tỷ lệ lợi ích - rủi ro và việc xác minh lợi ích lâm sàng. ADC Therapeutics đang đánh giá xem liệu dữ liệu bổ sung, các lựa chọn quản lý rủi ro hoặc thay đổi nhãn sản phẩm có thể giải quyết các lo ngại đó hay không.

Ban lãnh đạo cho biết các ca nhiễm trùng Độ 5 ghi nhận trong LOTIS-5 chủ yếu là do vi khuẩn. Không giống như LOTIS-5, đề cương LOTIS-7 khuyến nghị dự phòng và tiêm chủng bao phủ các bệnh nhiễm trùng do vi-rút, nấm và vi khuẩn, bao gồm PJP và vi-rút herpes. Công ty tin rằng những điểm khác biệt trong đề cương này có thể góp phần mang lại các kết quả an toàn khác nhau, nhưng kết quả cuối cùng của LOTIS-7 vẫn cần chờ báo cáo và sự xem xét của cơ quan quản lý.

Thời gian, thiết kế và chi phí cho một thử nghiệm Pha III tiềm năng của LOTIS-7 vẫn chưa được xác định. Công ty có kế hoạch thu thập ý kiến đóng góp từ cộng đồng y khoa và thảo luận về các phương án thiết kế khả thi với FDA.

Tóm tắt phiên hỏi đáp với chuyên gia phân tích

• Phê duyệt cấp tốc hiện tại: Ban lãnh đạo cho biết cuộc thảo luận với FDA chỉ tập trung vào LOTIS-5 và phác đồ kết hợp ZYNLONTA với rituximab. Công ty vẫn tự tin rằng đơn trị liệu ZYNLONTA sẽ duy trì được phê duyệt cấp tốc trong khi nỗ lực hướng tới phê duyệt đầy đủ thông qua LOTIS-5 hoặc một nghiên cứu khác.
• Các lựa chọn pháp lý cho LOTIS-5: ADC Therapeutics đang xem xét phản hồi từ FDA và cân nhắc dữ liệu bổ sung, các biện pháp quản lý rủi ro cũng như những sửa đổi đối với nhãn sản phẩm tiềm năng.
• Phát triển LOTIS-7: Ban lãnh đạo cho biết bản tóm tắt báo cáo gửi ASH phản ánh dữ liệu từ phần lớn trong số 100 bệnh nhân đã tham gia. Công ty có kế hoạch xin cấp chứng nhận liệu pháp đột phá và thảo luận về các phương án thiết kế Pha III với FDA.
• Đánh giá tác động về độ an toàn: Ban lãnh đạo không cho rằng tín hiệu nhiễm trùng Độ 5 của LOTIS-5 sẽ ảnh hưởng đến việc đưa LOTIS-7 vào dược thư, với lý do có sự khác biệt về phác đồ điều trị và đề cương dự phòng.
• Tác động thương mại: Công ty báo cáo không có sự thay đổi về sản lượng ZYNLONTA sau khi công bố thông tin LOTIS-5 và dự kiến nhu cầu đơn trị liệu đối với bệnh DLBCL từ phác đồ bước ba trở đi sẽ tiếp tục ổn định.

Toàn văn Biên bản Cuộc họp Kết quả Kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Q2 2026 Earnings Conference Call. [Operator Instructions] This call is being recorded on Thursday, August 13, 2026. I would now like to turn the conference over to Nicole Riley, Head of Investor Relations and Corporate Communications. Please go ahead.

Nicole Riley

Thank you, operator. Today, we issued a press release announcing our second quarter 2026 financial results and business update. This release and the slides we will use in today's presentation are available on the Investors section of the ADC Therapeutics website.

I'm joined on today's call by our Chief Executive Officer, Ameet Mallik, who will discuss our operational performance and recent business highlights; followed by our Chief Medical Officer, Mohamed Zaki, who will provide clinical and regulatory updates; and lastly, our Chief Financial Officer, Pepe Carmona, who will review our second quarter 2026 financial results. We will then open the call to questions.

Before we begin, I would like to remind listeners that some of the statements made during this conference call will contain forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain known and unknown risks and uncertainties, and actual results, performance and achievements could differ materially.

They are identified and described in the accompanying slide presentation and in the company's filings with the SEC, including Form 10-K, 10-Q and 8-K. ADC Therapeutics is providing this information as of today's date and does not undertake any obligation to update any forward-looking statements contained in this conference call as a result of new information, future events or circumstances, except as required by law. The company cautions investors not to place undue reliance on these forward-looking statements.

Today's presentation also includes non-GAAP financial reporting. These non-GAAP measures should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with GAAP. You should refer to the company's second quarter 2026 earnings release for information and reconciliation of historical non-GAAP measures to the comparable GAAP financial measures.

I will now turn the call over to our CEO, Ameet Mallik. Ameet?

Ameet Mallik

Thank you, Nicole. We are pleased to share that ZYNLONTA's commercial performance in the second quarter of 2026 continued to be broadly in line with recent quarters. We remain confident in the role ZYNLONTA will continue to play as a differentiated single-agent treatment option for third-line plus DLBCL patients.

Turning to our pipeline progress. As previously disclosed, we announced top line results for LOTIS-5 in June. Based on this data, we held a pre-sBLA meeting with the FDA. And following the meeting, we are assessing the best regulatory path forward. Mohamed will share more details regarding the FDA feedback and our regulatory strategy.

Further to this, the full LOTIS-5 data have now been submitted for presentation at ASH, and we are preparing to submit for publication with compendia submission to follow.

For LOTIS-7, we were pleased to complete enrollment of 100 patients at the selected dose level of ZYNLONTA plus glofitamab as shared in June and have submitted an abstract to ASH for presentation of the data, which we continue to believe demonstrate the most compelling combination data generated to date in second-line plus DLBCL with a safety profile generally consistent with prior LOTIS-7 disclosures.

With these data, we believe that ZYNLONTA plus glofitamab offers an opportunity to take a leading second-line position in the context of the evolving competitive landscape, solidifying ZYNLONTA as a foundational therapy in DLBCL. Beyond this, we are preparing to submit for publication of the LOTIS-7 data with compendia submission to follow. Simultaneously, we are exploring the potential regulatory pathway for this combination and expect to submit for breakthrough designation this year.

With respect to the multicenter investigator-initiated trials of ZYNLONTA in indolent lymphomas, updated marginal zone lymphoma data was submitted to ASH with publication and compendia submission to follow. Presentation of updated follicular lymphoma data is anticipated in the second quarter of 2027 with publication and compendia submission to follow. We also intend to assess potential regulatory pathways for these indolent lymphomas and expect to submit for breakthrough designation for MZL.

Moving now to corporate updates. We announced a strategic reorganization in June. As part of this, we implemented a reduction in our workforce of approximately 17% as well as additional operational efficiencies, resulting in cost savings of approximately $10 million on an annualized basis. As shared at that time, with these changes, we are resourced to deliver on our key clinical, regulatory and manufacturing activities while maintaining the full externally facing footprint to support the continued commercialization of ZYNLONTA in the third-line plus DLBCL setting.

Finally, we ended the second quarter of 2026 with a healthy cash balance of $219.1 million, maintaining our expected cash runway at least into 2028 and enabling us to deliver against our strategy.

Now I'd like to take a moment to remind everyone of our strategy to grow ZYNLONTA. Currently, ZYNLONTA plays a clear role in the third-line plus DLBCL setting. As monotherapy, ZYNLONTA has a well-established profile of rapid, deep and durable efficacy as well as manageable safety with simple and convenient administration. Since FDA accelerated approval in 2021, ZYNLONTA monotherapy has been used in treating approximately 5,000 patients in the U.S. We believe this is just a starting point as we see the potential for ZYNLONTA to reach significantly more patients by expanding use into earlier lines of therapy in DLBCL and into indolent lymphomas.

Now I would like to turn the call over to Mohamed, our CMO, to share more on our pipeline.

Mohamed Zaki

Thank you, Ameet. I would now like to share more on our LOTIS-5 and LOTIS-7 studies as we continue to work towards expansion of ZYNLONTA in earlier lines of DLBCL. As a reminder, LOTIS-5 is our Phase III confirmatory study of ZYNLONTA in combination with rituximab versus R-GemOx in patients with second-line DLBCL, which recently read out and met the primary endpoint of progression-free survival.

As noted, we held a meeting with the FDA in early August to present and discuss the totality of the LOTIS-5 data, along with the potential regulatory pathway. During this meeting, the FDA noted substantial concerns regarding the benefit risk or verification of clinical benefit observed in the LOTIS-5 trial. As such, the company is now assessing the regulatory path forward. We plan to provide an update on regulatory strategy and timing in the future. Beyond this, the data has been submitted to ASH. We are simultaneously pursuing publication for LOTIS-5 and potential compendia inclusion starting in 2027.

Turning now to LOTIS-7, our Phase Ib trial combining ZYNLONTA with the highly effective bispecific glofitamab in second-line plus DLBCL patients. We recently announced completion of enrollment of 100 patients at the 150 micrograms per kg dose. Of note, consistent with other glofitamab trials, the protocol for LOTIS-7 recommends prophylaxis, including vaccinations for viral, fungal and bacterial infections, including PJP and herpes virus, which was not part of the LOTIS-5 protocol.

Here, we continue to be encouraged by the promising LOTIS-7 data shared to date, which we believe demonstrates the potential for ZYNLONTA plus glofitamab to be the best-in-class combination. The data on a larger number of patients with longer follow-up has been submitted to ASH for presentation. This data supports the company's belief that ZYNLONTA plus glofitamab demonstrates the most compelling combination data generated to date in second-line DLBCL with a safety profile generally consistent with prior LOTIS-7 disclosures.

Separately, we are preparing for submission of the full LOTIS-7 data for publication and following that, plan to submit to compendia for potential inclusion starting in 2027. In addition, based on this potentially practice-changing LOTIS-7 data, the company plans to submit for breakthrough designation this year and is assessing a Phase III trial for the combination of ZYNLONTA plus glofitamab.

Moving forward, we plan to work closely with the FDA to determine the best path forward to achieve the full approval and advance ZYNLONTA combinations into earlier lines of therapy in DLBCL. In the meantime, we remain confident that ZYNLONTA will continue to play a meaningful role for patients with B-cell malignancies within its currently approved third-line plus DLBCL setting.

With that, I would like to turn the call over to Pepe Carmona, our CFO.

Jose Carmona

Thank you, Mohamed. On the financial front, ZYNLONTA net product revenues in the second quarter of 2026 were $18.6 million as compared to $18.1 million in the same quarter in 2025. Cost of product sales was $2.3 million and $6 million for the second quarter and 6 months ended June 30, 2026, as compared to $0.8 million and $2.9 million for the same period in 2025. The increases compared to prior year are primarily driven by a change in focus of personnel from research and development clinical supply activities to commercial manufacturing activities.

Total operating expenses were $44.7 million for the second quarter. On a non-GAAP basis, total adjusted operating expenses were $37.2 million for the quarter and were down by 22% over the prior year, primarily driven by lower R&D expenses. As Ameet noted, we expect to save an additional $10 million on an annual basis as a result of the strategic reorganization we announced in June.

On a GAAP basis, we reported a net loss of $16.6 million for the second quarter of 2026 as compared to a net loss of $56.6 million for the same period in 2025. The second quarter of 2026 included a onetime expense related to the strategic reorganization, while the year-ago quarter included restructuring, impairment and related costs from the June 2025 strategic reprioritization and restructuring plan.

On a non-GAAP basis, the adjusted net loss was $16.3 million for the second quarter of 2026 as compared to a net loss of $28.7 million for the same period in 2025. The lower net loss on a non-GAAP basis was primarily due to lower operating expenses. The year-over-year changes on a per share basis were additionally impacted by the higher number of weighted average shares outstanding.

You can find the reconciliation of GAAP to non-GAAP measures for the second quarter in the accompanying financial tables of the press release issued earlier today and in the appendix of this presentation. At the end of the second quarter, we had cash and cash equivalents of $219.1 million as compared to $231 million as of March 31, 2026, a change primarily driven by cash used in operations. This provides us with an expected cash runway at least into 2028.

With that, I will turn the call back over to Ameet. Ameet?

Ameet Mallik

Thank you, Pepe. To close, we are pleased by the commercial performance and the role that ZYNLONTA monotherapy continues to play in third-line plus DLBCL. We look forward to presentation of data from LOTIS-5, LOTIS-7 and MZL before year-end with publication and potential compendia inclusion to follow. Following the FDA pre-sBLA meeting, we are assessing regulatory approaches to determine the best path forward for the LOTIS-5 trial.

At the same time, we believe we have an opportunity for ZYNLONTA plus glofitamab to take a leading second-line position in DLBCL as a potential best-in-class bispecific combination and are actively assessing the potential regulatory path forward. Together, we anticipate we can grow ZYNLONTA beginning in 2027 as we work to make a meaningful difference in the lives of many more patients with B-cell malignancies.

We can now open the line for questions. Operator?

Operator

[Operator Instructions] Your first question comes from Eric Schmidt with Cantor.

Phần hỏi đáp

Eric Schmidt

Appreciate all the updates. Maybe just on the status of the current accelerated approval for ZYNLONTA, given the questions around risk benefit from LOTIS-5. Was there any FDA discussion of maintaining that accelerated approval status?

Ameet Mallik

Yes, great question. So first of all, all the discussions with the FDA were related only to the trial. All their comments were specific to the combination of ZYNLONTA plus rituximab on the trial. So there was no feedback at all about the single agent. So we remain confident that the monotherapy will stay on the market. We'll continue to have accelerated approval. And we're committed to working with the FDA to make sure that we can satisfy the full approval either through LOTIS-5 or through another study.

Eric Schmidt

And then on LOTIS-7 and your characterization of the most recent efficacy data that you guys have seen is compelling and consistent in safety. Have you essentially now seen the final ASH presentation? And do your comments pertain to that? In other words, do you know exactly what you'll present? And is it consistent with that statement?

Ameet Mallik

Yes. So we've already submitted the abstract for ASH, which contains obviously the vast majority of the 100 patients that we enrolled. So the belief that I'm sharing with you about the fact that we think we have very compelling efficacy and safety data is reflective of that ASH abstract. We obviously, for disclosure reasons, you can imagine we don't want to share all the details, but we do believe that we have very compelling data, both from an efficacy and a safety standpoint within the LOTIS-7 data that was submitted to ASH.

Eric Schmidt

And one more question, if I may, with regard to exploring a Phase III pathway for the combination in LOTIS-7. Is that something you're exploring with Roche or by yourselves?

Ameet Mallik

I don't want to comment on that. Obviously, we have a great partnership with Roche, and they've given us great feedback throughout. But what I would say is we've had lots of discussions, but also lots of thought, as you can imagine, even independent of the feedback from the FDA about a potential Phase III design because we know that this data is so compelling that there could be significant upside for the asset by potentially pursuing a Phase III trial. So it's something we've been thinking about for a long time. The team has already been preparing on different design options, and we do plan to file for breakthrough designation this year and to discuss with the FDA potential designs.

Operator

Your next question comes from Michael Schmidt with Guggenheim Securities.

Unknown Analyst

This is Sarah on for Michael. Just wanted to follow on quickly on the Phase III plans, whether you could give any color on sort of time line for that now that it appears to be sort of more of the future-looking focus. And then additionally, I had a sort of a question on the LOTIS-5 data. So I know you've mentioned the 105-day period for monitoring adverse events after treatment. I was wondering if you could comment on the timing of the deaths.

Ameet Mallik

So first of all, I just want to emphasize we have a positive study for LOTIS-5. So we still are assessing possibilities to identify the best regulatory approach for LOTIS-5. I mean specifically, we're considering whether additional data risk management options or modifications to the potential label can address the FDA concern. So we are doing that.

In parallel, given that we have, we think, potentially practice-changing data on hand with the LOTIS-7, we're also in parallel going to file for breakthrough designation and explore a Phase III approach there. So it's too premature at this point, as you can imagine, while we're still gathering input from the medical community and obviously have to talk with the FDA on the final design to talk about timing and costs. But I just want to reemphasize that those 2 things are going in parallel.

And then with regards to the 105-day safety window in terms of capturing AEs post the last dose, that's the same, by the way, in LOTIS-7 as well. And one thing I want to emphasize is that as Mohamed mentioned on the call, there was a big difference between LOTIS-5 and LOTIS-7, particularly with regards to the prophylactic measures taken. So in LOTIS-7, consistent with a lot of the other -- with the other glofitamab trials that have been run, LOTIS-7 recommends prophylaxis, including vaccinations for viral, fungal and bacterial infections. That was not part of the LOTIS-5 protocol. So while the time period that we're capturing AEs is very similar, there was a pretty big difference in terms of prophylaxis in the protocol between 5 and 7.

Operator

Your next question comes from Maury Raycroft with Jefferies LLC.

Unknown Analyst

This is James on for Maury. Can you provide more detail on the type of Grade 5 infections that were observed in LOTIS-5 and whether those events would have been expected to be mitigated by the prophylactic and vaccination strategies now incorporated in LOTIS-7? Did other infections occur that aren't addressed by those vaccines? And I have a follow-up after that.

Ameet Mallik

Yes. So the primary type of infections were bacterial, which is why we think that prophylaxis could play a role.

Unknown Analyst

Got it. And how do you think about the potential read-through from LOTIS-5 Grade 5 signal to potential NCCN compendia inclusion and adoption of the ZYNLONTA glofitamab combination within the academic community? Could LOTIS-5 impact the NCCN language? And could there be any safety monitoring requirements?

Ameet Mallik

Yes. I don't think there will be any read-through in terms of LOTIS-7 compendia inclusion. Two very different studies, 2 different regimens. As I mentioned, the protocol is different, which we think can help to contribute to some of the safety differences. Just as a reminder, obviously, I can't speak to the data that we have on hand, but I can speak to the prior disclosure that we had. We had a very low percent of Grade 5 events, approximately 4% if you look at our last disclosure we had in December on the 49 patients that we reported. So I do think there's a difference and we don't think there would be a read-through to LOTIS-7 or to any potential NCCN or compendia inclusion.

Operator

We now have a question from Leonid Timashev with RBC Capital Markets.

Unknown Analyst

Josh on for Leo here. I was wondering whether or not the FDA in their feedback in response to the Phase III, did they provide any kind of indication of what an effective path forward might look like and what strategies you guys are thinking about at the time being?

Ameet Mallik

Yes. And I think typical in what you have in the pre-sBLA meeting, we share the data results and you're aligning on the package for an sBLA submission. During that, as it is typical with any other pre-sBLA meeting, they share concerns that they have with the data. And so right now, we're basically going through the feedback and assessing whether additional data risk management options or modification to the potential label can help to address those FDA concerns. And that's the basis of which we're evaluating our path forward for LOTIS-5.

Operator

[Operator Instructions] Your next question comes from Rob Burns with H.C. Wainwright.

Unknown Analyst

This is Ahmed on for Rob. I was just wondering if you saw Q2 product revenue increase versus Q2 '25. And I was wondering if you've seen any changes in patient starts or unit demand dosing or physician prescribing behaviors since LOTIS-5 disclosure? And then for my second question, I was wondering if in your conversations with the FDA, did they focus on the PFS in patients 75 or older, and if that would influence eligibility criteria or future label?

Ameet Mallik

Yes. So with regard to sales, we haven't seen any impact. If you look at the volume in Q2, very consistent with prior quarters. So -- and we don't think that there will be. If you look overall over the past several quarters, the commercial performance of the monotherapy in the third-line plus setting has been relatively consistent. And that's because ZYNLONTA has an established place in the third-line plus setting, and we don't expect any impact on monotherapy sales.

And then remind me again, I'm sorry, your second question.

Unknown Analyst

No problem. I was wondering if...

Ameet Mallik

Oh, just about patients 75 or older, right?

Unknown Analyst

Yes.

Ameet Mallik

Yes. We don't think it will have any impact on other studies. I think obviously, older patients specifically with infection, we think that the prophylaxis can play a role. And that's also why the protocol, again, I want to stress the LOTIS-7 versus LOTIS-5 are quite different. So I think each study is on its own. I don't think that there's a read-through from this. We certainly learned a lot from LOTIS-5, and we're happy with the differences in the protocol, of course, that we're seeing in LOTIS-7. So we don't see any read-through from LOTIS-5 to either the current indication or other potential combinations.

Operator

There are no further questions at this time. So I will now turn the call over to Ameet Mallik for closing remarks. Please continue.

Ameet Mallik

Well, thank you all for joining the call today and for your continued support. We look forward to keeping you updated on our progress. Operator, you may now end the call.

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.