1. ZYNLONTA and glofitamab show strong efficacy in DLBCL patients. 2. Combination has 89.8% overall response rate and 77.6% complete response rate. 3. LOTIS-7 trial expected to complete enrollment in early 2026. 4. Management cites potential best-in-class outcomes for ZYNLONTA combinations. 5. Company plans to share full results at medical congress by late 2026.
FAQ
Why Bullish?
The strong data on ZYNLONTA's efficacy and safety enhances investor confidence, similar to previous successful trial results for ADCs, which have often resulted in price increases.
How important is it?
The ongoing trials and strong efficacy data have notable implications for ADCT’s growth, making this information critical for potential investors and analysts.
Why Long Term?
With enrollment completing in 2026 and full data expected, impacts will unfold over time, akin to past industry patterns where trial completion leads to negotiations and potential approvals.
ADC Therapeutics Reports Promising Data on ZYNLONTA® for DLBCL
ADC Therapeutics (NYSE: ADCT), a leader in antibody drug conjugate (ADC) innovation, has released updated findings from the LOTIS-7 Phase 1b clinical trial. This study evaluates the safety and efficacy of ZYNLONTA® in combination with the bispecific antibody glofitamab (COLUMVI®) for patients diagnosed with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Trial Overview and Efficacy Data
As of the cutoff date on November 17, 2025, data from 49 patients participating in the LOTIS-7 trial demonstrated significant efficacy:
- Overall Response Rate (ORR): 89.8% (44 out of 49 patients)
- Complete Response (CR) Rate: 77.6% (38 out of 49 patients)
- Durability of Responses: 33 of the 38 patients who achieved CR are still in remission as of the data cutoff.
- Relapsed Population Performance: Among 24 relapsed patients, the ORR was 100% with a CR rate of 91.7%.
- Primary Refractory Population Performance: In 25 primary refractory patients, the ORR stood at 80%, with a CR rate of 64%.
Additionally, 14 patients transitioned from stable disease (SD) or partial response (PR) to complete response over time, reflecting robust therapeutic potential.
Safety Profile
The combination treatment of ZYNLONTA and glofitamab is reported to be generally well tolerated:
- Grade 3 or higher treatment-emergent adverse events (TEAEs): Neutropenia (32.7%), increased GGT (16.3%), anemia (10.2%), among others.
- Grade 5 AEs: Occurred in 4.1% of patients, with one being treatment-related.
- Cytokine Release Syndrome (CRS): Reported in 36.7% of patients, with all grades observed.
These findings illustrate a manageable safety profile, further validating the potential of ZYNLONTA as a key treatment option for r/r DLBCL patients.
Future Directions and Conference Call
ADC Therapeutics is on track to complete enrollment of approximately 100 patients in the LOTIS-7 trial by the first half of 2026. They plan to share full results at a medical congress and submit them for publication by the end of 2026. The company will also evaluate regulatory strategies to advance ZYNLONTA’s potential.
Dr. Mohamed Zaki, Chief Medical Officer of ADC Therapeutics, expressed excitement about the data, stating, “These results align with our goal of improving outcomes for patients with 2L+ r/r DLBCL.” Ameet Mallik, CEO, emphasized the combination's potential as a best-in-class treatment.
A conference call regarding this announcement is set for today at 8:00 a.m. EST. Registration is required to access the call, and it will also be available via webcast on the ADC Therapeutics investors' webpage.
About LOTIS-7
LOTIS-7 is a Phase 1b global multicenter, multi-arm trial focusing on patients with B-cell non-Hodgkin lymphoma (B-NHL). It includes dosing arms for ZYNLONTA with multiple bispecific monoclonal antibodies and aims to establish safety and efficacy across various patient populations.
The primary and secondary endpoints encompass safety, overall response rate (ORR), duration of response (DOR), and other critical benchmarks. More details can be found at clinicaltrials.gov under NCT04970901.
About ZYNLONTA®
ZYNLONTA® is an FDA and EMA-approved CD19-directed ADC, offering treatment options for adult patients with r/r large B-cell lymphoma. It leverages a potent payload that induces cell death effectively by targeting CD19-expressing cells. The approval’s continuing status is contingent on confirming clinical benefits in future trials.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is dedicated to pioneering advancements in the ADC field, as evidenced by their innovative portfolio, including ZYNLONTA. Their ongoing dedication to research and development positions them at the forefront of cancer therapy breakthroughs.