ADC Therapeutics Announces Abstracts at the 68th ASH Annual Meeting Highlighting Breadth of ZYNLONTA® Clinical Program
LOTIS-5 improved its primary endpoint, while Grade 5 adverse-event comparisons differed by reporting window.
Sentiment and the balance of points
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Rhea-AI Summary
ADC Therapeutics (NYSE: ADCT) announced ZYNLONTA clinical results for presentation at the ASH Annual Meeting on December 12–15, 2026. In Phase 1b LOTIS-7, ZYNLONTA plus glofitamab produced an 88.7% overall response rate and 75.3% complete response rate among 97 efficacy-evaluable patients. In a Phase 2 marginal zone lymphoma study, those rates were 93% and 74.4% among 43 efficacy-evaluable patients; two-year progression-free survival was 90.8%.
In the 420-patient Phase 3 LOTIS-5 trial, ZYNLONTA plus rituximab improved median progression-free survival—time without disease worsening—to 6.14 months versus 4.73 months with R-GemOx. Overall survival did not differ statistically. Grade 5 adverse-event rates were 13.2% versus 4.6% within the protocol-defined 105-day reporting window, but 1.5% versus 3.0% using a 30-day post-treatment window. The company plans Phase 3 studies and is pursuing potential compendia and regulatory pathways.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointLOTIS-5 median progression-free survival improved to 6.14 versus 4.73 months with R-GemOx; P=0.0083.
- Moderate pointLOTIS-7 combination treatment achieved 88.7% overall response and 75.3% complete response among 97 efficacy-evaluable patients.
- Moderate pointLOTIS-7 median response duration, complete-response duration and progression-free survival were not reached at 10.35-month median follow-up.
- Moderate pointMarginal zone lymphoma monotherapy achieved 93% overall response and 74.4% complete response among 43 efficacy-evaluable patients.
- Moderate pointMarginal zone lymphoma two-year progression-free survival was 90.8% at 23.2-month median follow-up.
- Moderate point. Forward-looking: it has not happened yet and may not happen.ADC Therapeutics plans Phase 3 studies and is pursuing potential compendia and regulatory pathways.
9 minor points
- Minor pointLOTIS-5 overall response was 58.1% versus 45.2%; complete response was 39.5% versus 26.7% with R-GemOx.
- Minor pointLOTIS-5 median complete-response duration was 16.82 versus 12.25 months with R-GemOx.
- Minor pointLOTIS-5 complete responses persisted at 24 months in 48.5% versus 16.7% of complete responders.
- Minor pointLOTIS-5 Grade 3 or higher events affected 74.0% versus 76.1% within the 105-day reporting window.
- Minor pointLOTIS-7 primary-refractory patients achieved 78.4% overall response and 64.7% complete response.
- Minor pointLOTIS-7 patients previously treated with CAR-T therapy achieved 74.1% overall response and 63.0% complete response.
- Minor pointLOTIS-7 complete-response durability at 12 months was 79.0%.
- Minor pointLOTIS-7 exploratory residual-disease testing found 11 of 12 complete responders had undetectable disease at treatment end.
- Minor pointMarginal zone lymphoma 24-month response-duration rate was 90.9%.
Negative
- Moderate pointLOTIS-5 showed no statistically significant overall-survival difference between treatment arms.
- Moderate pointLOTIS-5 Grade 5 events were 13.2% versus 4.6% over 105 days; 30-day post-treatment rates were 1.5% versus 3.0%.
- Minor pointLOTIS-7 reported three Grade 5 treatment-emergent adverse events.
- Minor pointLOTIS-7 cytokine release syndrome affected 32%, predominantly Grade 1–2; one Grade 3 event occurred.
- Minor pointMarginal zone lymphoma Grade 3 adverse events affected 23 patients (50%), totaling 36 events.
2 minor points
- Minor pointMarginal zone lymphoma Grade 4 adverse events affected five patients (10.9%), totaling five events.
- Minor pointMarginal zone lymphoma treatment required dose reductions in four patients.
Details
Market move: ADCT +8.39% vs previous close. ZYNLONTA clinical data
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Key Figures
- LOTIS-7 efficacy-evaluable patients
- 97 patients
- ZYNLONTA plus glofitamab, Phase 1b
- LOTIS-7 ORR
- 88.7%
- ZYNLONTA plus glofitamab
- LOTIS-7 CRR
- 75.3%
- ZYNLONTA plus glofitamab
- MZL ORR
- 93%
- Phase 2 investigator-initiated study
- MZL CRR
- 74.4%
- Phase 2 investigator-initiated study
- LOTIS-5 median PFS
- 6.14 vs. 4.73 months
- Independent review; ZYNLONTA plus rituximab vs. R-GemOx
- LOTIS-5 PFS hazard ratio
- 0.73; 95% CI 0.57–0.92; p=0.0083
- ZYNLONTA plus rituximab vs. R-GemOx
- LOTIS-5 Grade 5 events
- 13.2% vs. 4.6%
- Protocol-defined 105-day treatment-emergent adverse event window; ZYNLONTA plus rituximab vs. R-GemOx
Historical Context
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The prior update reported FDA benefit-risk concerns for LOTIS-5 and LOTIS-7 enrollment completion.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
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pfs medical
mrd medical
cytokine release syndrome medical
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AI-generated analysis. How Rhea-AI works. Not financial advice.
ZYNLONTA data to be featured across 5 oral presentations and multiple posters
Phase
Phase 2 marginal zone lymphoma IIT abstract shows robust and durable
Company to host conference call today at 4:15 p.m. EST
LAUSANNE,
Across the presentations, the data provide additional insight into the depth and durability of response observed with ZYNLONTA across multiple B-cell lymphomas and treatment settings, including in difficult-to-treat patient populations. Oral presentations include expanded
"We are pleased by the breadth of the ZYNLONTA clinical program and the growing body of evidence showcased through multiple presentations at ASH," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "We are particularly encouraged by the strength of the updated
"We believe the emerging data from
Select Oral Presentations: Clinical Highlights
As of the June 15, 2026 data cutoff, at the ZYNLONTA 150 µg/kg starting dose + glofitamab:
- Among 97 efficacy-evaluable patients, the overall response rate (ORR) was
88.7% , and the complete response rate (CRR) was75.3% . - Patients had received a median of one prior treatment (range 1-5);
52.4% were primary refractory - In patients with primary refractory disease, ORR was
78.4% and CRR was64.7% . Among patients previously treated with prior CAR-T therapy, ORR was74.1% and CRR was63.0% . - At a median follow-up of 10.35 months, median duration of response, duration of complete response and progression-free survival (PFS) had not been reached. The 12-month duration of complete response rate was
79.0% . - In an exploratory MRD analysis of 12 patients who achieved a complete response,
50% achieved undetectable MRD as early as Cycle 2, Day 1, and 11 had undetectable MRD at end of treatment. - Cytokine release syndrome (CRS) occurred in
32% of treated patients, predominantly Grade 1 (25.2% ) or 2 (5.8% ). One Grade 3 CRS event was reported, and no Grade 3 or higher ICANS events occurred. Three Grade 5 treatment-emergent adverse events were reported.
Authors conclude that the efficacy and safety findings support further investigation of ZYNLONTA plus glofitamab in a Phase 3 study.
Phase 2 IIT: Fixed-duration ZYNLONTA in relapsed or refractory marginal zone lymphoma
An investigator-led, multicenter Phase 2 study demonstrated high response rates and encouraging durability with fixed-duration ZYNLONTA in patients with relapsed or refractory MZL.
As of the July 1, 2026 data cutoff:
- Among 43 efficacy-evaluable patients, ORR was
93% and CRR was74.4% . - Patients had received a median of two prior treatments;
37% had primary refractory disease and42% had experienced disease progression within 24 months of initial therapy. - At a median follow-up of 23.2 months, the two-year PFS rate was
90.8% . - The duration of response rate at 24 months was
90.9% . - Among 46 treated patients, adverse events (AEs) were predominantly Grade 1–2. Grade 3 AEs (36 events) were reported in 23 patients (
50% ), and Grade 4 AEs (5 events) in five patients (10.9% ). The most common Grade 3 events included anemia (n=5), lung infections (n=5), elevated ALT (n=4), alkaline phosphatase (n=3) and AST (n=1). Grade 4 events included neutropenia (n=2), thrombocytopenia (n=2) and hyponatremia (n=1). Four patients required dose reductions.
Authors conclude that ZYNLONTA demonstrated clinically meaningful activity with robust and durable complete responses in relapsed or refractory MZL, characterizing the responses as comparable with those reported for recently approved CAR-T therapy.
Phase
Full results from the randomized Phase
As of the data cutoff of February 16, 2026:
- Median PFS by independent review was 6.14 months with ZYNLONTA plus rituximab versus 4.73 months with R-GemOx (HR 0.73;
95% CI, 0.57–0.92; P=0.0083). - ORR was
58.1% versus45.2% , and CRR was39.5% versus26.7% , respectively. - Median duration of complete response was 16.82 months versus 12.25 months. At 24 months,
48.5% versus16.7% of patients who achieved a complete response remained in complete response. - No statistically significant difference in overall survival was observed between treatment arms.
- Within the protocol-defined 105-day treatment-emergent adverse event reporting window, Grade 3 or higher events occurred in
74.0% versus76.1% of patients, and Grade 5 events occurred in13.2% versus4.6% , respectively. Using a standard 30-day post-treatment window, Grade 5 events occurred in1.5% versus3.0% , respectively.
Authors conclude these findings establish ZYNLONTA plus rituximab as a standard treatment option in the second-line or later setting.
Presentation Details
Oral presentation details are as follows:
|
Abstract # |
Title |
Presentation Details |
Presenter |
|
#238 |
Loncastuximab Tesirine Consolidation After Short-Course R-BAC Induction in BTKi-Exposed R/R Mantle Cell Lymphoma: Primary Endpoint Analysis from the Phase II Column Trial from Fondazione Italiana Linfomi (FIL) |
Saturday, December 12, 2026 2:45 PM - 3:00 PM CT Location: New Orleans Theatre A |
Rita Tavarozzi, MD, University of Eastern Piedmont, |
|
#619 |
Updated Results from LOTIS-7: A Phase 1b Study Evaluating the Safety and Efficacy of Loncastuximab Tesirine in Combination with Glofitamab in Patients with Relapsed or Refractory Large B-Cell Lymphoma |
Sunday, December 13, 2026 12:00 - 12:15 p.m. CT Location: New Orleans Theatre B |
Juan P. Alderuccio, MD, Clinical Site Disease Group Leader, Lymphoma Section, at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, Miami, FL, USA |
|
#783 |
Phase II Trial of Loncastuximab Tesirine (WM-NET1 Trial) in Patients with Relapsed/Refractory and High-Risk Waldenström Macroglobulinemia |
Monday, December 14, 2026 11:00 - 11:15 AM CT Location: New Orleans Theatre B |
Shayna Sarosiek, MD, Bing Center for Waldenström Macroglobulinemia, Division of Hematological Malignancies, Dana-Farber Cancer Institute, |
|
#784 |
Fixed-Duration Loncastuximab Tesirine Induces a High Rate of Complete and Durable Responses in Patients with Relapsed/Refractory Marginal Zone Lymphoma - Report of a Multicenter Phase II Study |
Monday, December 14, 2026 11:15 - 11:30 a.m. CT Location: New Orleans Theatre B |
Izidore S. Lossos, MD, Chief, Division of Hematology Lymphoma Section, Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, |
|
#920 |
Results From the Phase 3 LOTIS‑5 Study: Efficacy and Safety of Loncastuximab Tesirine plus Rituximab vs Immunochemotherapy (R-GemOx) in Patients with Relapsed or Refractory DLBCL |
Monday, December 14, 2026 3:00 - 3:15 p.m. CT Location: New Orleans Theatre A |
Mehdi Hamadani, MD, Division of Hematology and Oncology, Medical College of |
Conference Call Information
To access today's conference call, please register here. The participant toll-free dial-in number is 1-800-836-8184 for North America and Canada. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.
About ZYNLONTA®
ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.
The
ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio with ZYNLONTA® (loncastuximab tesirine-lpyl). ADC Therapeutics' CD19-directed ADC ZYNLONTA received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. Headquartered in Lausanne (Biopôle), Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization. Learn more at adctherapeutics.com and follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and our ability to maintain accelerated approval in the United States and foreign jurisdictions for our product; our ability to identify and execute on potential regulatory and compendia pathways; the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA including our ability to adequately address the serious concerns related to the LOTIS-5 trial results raised by the FDA at the recent pre-sBLA submission meeting; the timing, submission and outcome of an sBLA related to LOTIS-5 and potential approval; the actual and perceived benefit-risk profile for ZYNLONTA as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for safety, efficacy and within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for ZYNLONTA in the United States and foreign jurisdictions and into earlier lines of therapy; the timing and publication of the full LOTIS-7 trial data and potential NCCN compendia inclusion; future regulatory strategy for a Phase 3 trial for the combination of ZYNLONTA plus glofitamab and the timing and results of such trial; the timing and publication of the investigator-initiated trials studying FL and MZL and the potential NCNN compendia inclusion and regulatory strategy and the future opportunity; the impact, if any, from the various abstracts and presentations at ASH; whether Tanabe's marketing authorization application filed with Japan's Ministry of Health for ZYNLONTA will be accepted, the timing and potential approval of the marketing authorization application for ZYNLONTA in Japan, the timing and payment of future regulatory and commercial milestones related to Japan, Nippon Shinyaku ability to successfully commercialize ZYNLONTA in Japan and the amount of future revenue in Japan and related payments to ADCT; our expected revenue growth in 2027 and the Company's ability to sustain or grow ZYNLONTA revenue in the future; our expected cash runway into 2029; changes in our regulatory and commercial strategy; the ability of our partners to commercialize ZYNLONTA in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain or maintain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's future clinical trials and investigator initiated trials; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; our ability to effect the proposed amendments to the HCR agreement and the loan agreement; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; uncertainties related to a potential change in domicile from Switzerland to Delaware, including the outcome of tax analyses associated with such redomiciliation, the receipt of requisite shareholder approval, and the ability to complete the redomiciliation on the anticipated terms and timeline, if at all; and the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business, financial condition, and results of operations. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document.
CONTACTS:
Investors and Media
Nicole Riley
ADC Therapeutics
Nicole.Riley@adctherapeutics.com
+1 862-926-9040
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SOURCE ADC Therapeutics SA
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did ADC Therapeutics report from the ZYNLONTA LOTIS-7 trial?
ZYNLONTA plus glofitamab achieved an 88.7% overall response rate and 75.3% complete response rate among 97 efficacy-evaluable patients. These Phase 1b results used a ZYNLONTA starting dose of 150 µg/kg and a June 15, 2026 data cutoff. Patients had received a median of one prior treatment.
Did ADC Therapeutics' LOTIS-5 trial meet its primary endpoint?
LOTIS-5 demonstrated a statistically significant improvement in progression-free survival, its primary endpoint, with ZYNLONTA plus rituximab versus R-GemOx. Independent review found median progression-free survival of 6.14 versus 4.73 months, with a hazard ratio of 0.73 and P=0.0083. There was no statistically significant overall-survival difference.
Which severe adverse events occurred in ADC Therapeutics' marginal zone lymphoma study?
Among 46 treated patients, 23 patients (50%) had Grade 3 adverse events and five patients (10.9%) had Grade 4 events. Grade 3 events included anemia, lung infections and elevated liver enzymes. Grade 4 events included neutropenia, thrombocytopenia and hyponatremia—low neutrophil, platelet and blood sodium levels, respectively. Four patients required dose reductions.