On January 8, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported corporate updates and highlights from its ZYNLONTA clinical program.

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"During 2025, we delivered meaningful progress across our ZYNLONTA clinical program and extended our expected cash runway at least to 2028," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This year, we look forward to multiple clinical catalysts including full results from our LOTIS-5 and LOTIS-7 2L+ DLBCL trials, as well as potentially from the ongoing Phase 2 indolent lymphoma IITs. Assuming positive results, we anticipate potential compendia inclusion for each in the first half of 2027 with LOTIS-5 regulatory approvals to follow. Taken together, we anticipate we will see an acceleration in net product revenue growth beginning in 2027."

Recent Highlights and Developments

Preliminary unaudited 2025 selected financial results. ZYNLONTA net product revenue is expected to be approximately $73 million for full year 2025 compared with $69.3 million for full year 2024. Fourth quarter 2025 ZYNLONTA net product revenue is expected to be approximately $22 million, as compared to $16.4 million in the fourth quarter of 2024, primarily reflecting variability in customer ordering. Underlying demand for ZYNLONTA in the current 3L/3L+ DLBCL indication remained broadly stable year-over-year. The Company ended 2025 with cash and cash equivalents of approximately $261 million which, based on current plans, is expected to provide a cash runway at least to 2028.

Reported updated data from LOTIS-7 in December 2025. Updated data from the LOTIS-7 Phase 1b clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) demonstrated an 89.8% best overall response rate (ORR) and a 77.6% complete response rate across 49 efficacy evaluable patients with a minimum of 6 months follow-up. Enrollment in the LOTIS-7 trial is ongoing, with complete enrollment of approximately 100 patients at the selected 150 µg/kg dose expected during the first half of 2026. The Company plans to share full data at a medical meeting and through publication by the end of 2026. In addition, the Company plans to assess regulatory and compendia strategies in the first half of 2027.

LOTIS-5 topline results anticipated in 2Q 2026. The Company expects to provide topline data in 2Q 2026 from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab in patients with 2L+ DLBCL once the pre-specified number of approximately 262 progression-free survival (PFS) events is reached and data are available. Publication of the full results is anticipated by the end of 2026. Assuming positive results, a supplemental Biologics License Application (sBLA) submission to the U.S. FDA will follow, with potential compendia inclusion in the first half of 2027 and confirmatory approval in 2L+ DLBCL in mid-2027.

Investigator-initiated trials (IITs) of ZYNLONTA in indolent lymphomas ongoing. Initial data from the Phase 2 clinical trial evaluating ZYNLONTA in combination with rituximab to treat relapsed or refractory (r/r) follicular lymphoma (FL) and the Phase 2, single-arm, open-label, multicenter trial of ZYNLONTA to treat r/r marginal zone lymphoma (MZL) led by the Sylvester Comprehensive Cancer Center at University of Miami have shown promising efficacy and manageable safety results. The Company anticipates publication of both data sets as early as the end of 2026. Assuming positive data, the Company plans to assess regulatory and compendia strategies.

IND-enabling activities completed for PSMA-targeting ADC. IND-enabling activities for the Company’s exatecan-based, prostate-specific membrane antigen (PSMA)-targeting ADC were completed at the end of 2025. The Company continues to explore partnership opportunities.

(Press release, ADC Therapeutics, JAN 8, 2026, View Source [SID1234661842])