ADC Therapeutics Releases Phase 3 Data for Zynlonta
ADC Therapeutics announced topline data from its Phase 3 LOTIS-5 confirmatory trial evaluating Zynlonta - loncastuximab tesirine-lpyl - in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma, or r/r DLBCL. Zynlonta plus rituximab achieved statistical significance on the trial's primary endpoint of progression-free survival and demonstrated no detrimental effect on the key secondary efficacy endpoint of overall survival. In addition, a higher complete response rate and duration of CRs were observed with Zynlonta plus rituximab. Overall, treatment emergent adverse event, or TEAE, rates were similar between arms, with hematologic TEAEs higher in the control arm and infection, hepatotoxicity, and edema/effusion higher in the test arm. Serious adverse events, TEAEs leading to study drug withdrawal, and Grade 5 events were higher in the test arm, with the majority of Grade 5 TEAEs in the test arm occurring in patients aged 75 years or older. ADC plans to discuss the benefit-risk profile of this combination with the FDA as it prepares for the planned supplemental Biologics License Application filing. ADBC intend to conduct a pre-sBLA meeting in August and is preparing for a planned sBLA submission in Q4. In addition, the company will continue to evaluate a broad range of value maximizing alternatives, including but not limited to near-term cost reduction initiatives.
Trade with 70% Backtested Accuracy
Analyst Views on ADCT
About ADCT
About the author

- Investigation Launched: Pomerantz LLP is investigating ADC Therapeutics SA for potential securities fraud or other unlawful business practices, aiming to protect investor rights and pursue legal remedies.
- Clinical Trial Results: On June 3, 2026, ADC announced topline data from its Phase 3 LOTIS-5 trial showing that ZYNLONTA® combined with rituximab extended progression-free survival by 1.4 months in patients with relapsed or refractory DLBCL, but resulted in 27 deaths compared to 9 in the immunotherapy group.
- Stock Price Plunge: Following the disappointing trial results, ADC's stock price fell by $2.05, or 66.56%, over the next two trading sessions, closing at $1.03 per share on June 5, 2026, reflecting market pessimism about the company's future prospects.
- Legal Implications: Pomerantz LLP, recognized for its expertise in securities class action litigation, has historically recovered multimillion-dollar damages for victims of securities fraud, indicating that this investigation could lead to significant legal consequences for ADC.
- Investigation Launched: Pomerantz LLP is investigating ADC Therapeutics SA for potential securities fraud or other unlawful business practices, aiming to protect investor rights and possibly initiate a class action lawsuit.
- Clinical Trial Results: On June 3, 2026, ADC announced that its Phase 3 LOTIS-5 trial showed ZYNLONTA® extended progression-free survival by 1.4 months in patients with relapsed or refractory DLBCL, but the treatment group experienced significantly more deaths compared to the immunotherapy arm.
- Stock Price Plunge: Following the trial results, ADC's stock price fell by $2.05, or 66.56%, over the next two trading sessions, closing at $1.03 per share on June 5, 2026, indicating strong market concerns regarding the treatment's efficacy.
- Legal Implications: The investigation could lead to legal liabilities for ADC, and if fraud is confirmed, it may have significant negative impacts on the company's reputation and future financing capabilities.
- Trial Results Impact: ADC Therapeutics' Phase 3 LOTIS-5 trial showed a median progression-free survival of 6.1 months for Zynlonta combined with rituximab, significantly higher than the control group's 4.7 months; however, the overall survival did not demonstrate superiority, leading to a drastic market reaction with shares plummeting over 50% in premarket trading.
- Safety Concerns: While the rate of treatment-emergent adverse events was similar between the groups (98.5% vs. 97.5%), the experimental arm had a significantly higher rate of serious adverse events at 49.0%, which may affect physician acceptance of the therapy and negatively impact future sales.
- Regulatory Path Dependency: The continued availability of Zynlonta in the U.S. hinges on positive results from confirmatory trials, and ADC Therapeutics plans to submit a supplemental Biologics License Application based on trial data; failure to secure FDA approval could severely impact the company's revenue.
- Cost Control Measures: The company indicated it will continue its cost reduction initiatives and other value-enhancing measures to navigate current market challenges, emphasizing the need to maintain operational sustainability despite significant stock price declines.
- Clinical Trial Success: ADC Therapeutics' LOTIS-5 trial demonstrated that the combination of ZYNLONTA and rituximab achieved statistical significance in progression-free survival (PFS) with a median PFS of 6.1 months compared to 4.7 months in the control group, indicating a significant therapeutic effect.
- Efficacy Metrics Improvement: The combination therapy showed a complete response (CR) rate of 39.5% versus 26.7% in the control group, highlighting its potential to provide a new treatment option for patients by significantly enhancing response rates.
- Safety Analysis: While the treatment-emergent adverse event (TEAE) rates were similar between the ZYNLONTA plus rituximab group (98.5%) and the control group (97.5%), the higher rate of serious adverse events (SAEs) in patients aged 75 and older in the ZYNLONTA group indicates a need for careful risk assessment in elderly patients.
- FDA Application Plans: Following the positive results from LOTIS-5, ADC Therapeutics plans to submit a supplemental Biologics License Application (sBLA) in Q4 2026 and will hold a pre-sBLA meeting with the FDA in August to discuss the benefit-risk profile of this combination.
- Revenue Growth: In Q1 2026, ADC Therapeutics reported net product revenues of $20 million, up from $17.4 million in the same quarter last year, primarily driven by normal fluctuations in customer orders, indicating stable market demand and the company's ability to maintain strong sales momentum in a competitive environment.
- Cost Management: The cost of product sales rose to $3.6 million in the first quarter, an increase of $1.6 million from the previous quarter, reflecting a shift in personnel cost allocation from research and development to commercial manufacturing, while the company actively optimizes its cost structure to maintain financial health.
- Cash Flow Status: As of the end of Q1 2026, ADC Therapeutics had cash and cash equivalents of $231 million, down from $261.3 million at the end of 2025, yet still maintaining a healthy cash flow that supports future R&D and market expansion initiatives.
- Future Outlook: Management expects to share top-line data for LOTIS-5 by the end of June, and if results are positive, plans to submit a supplemental biologics license application to the FDA by year-end, demonstrating the company's confidence in new product launches and its strategic grasp of market opportunities.
- Revenue Performance: ADC Therapeutics reported a Q1 non-GAAP EPS of -$0.13 with revenues of $20.85 million, reflecting a 9.5% year-over-year decline but exceeding expectations by $0.86 million, demonstrating resilience amid market fluctuations.
- Product Revenue Growth: The net product revenue for Q1 reached $20 million, up from $17.4 million in Q1 2025, primarily driven by normal variability in customer ordering patterns and price increases, indicating stability in product demand.
- Decline in License Revenue: License revenues and royalties fell to $0.8 million from $5.6 million in Q1 2025, primarily due to a milestone payment received in the prior year, highlighting the volatility in revenue sources.
- Cash Flow Status: As of March 31, 2026, cash and cash equivalents stood at $231 million, with an expected cash runway extending at least into 2028, ensuring operational stability for the company in the coming years.









