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ADC’s Label-Expansion Study For Zynlonta Halted For Respiratory Safety

 
• By Joseph Haas

A Phase II study in a frail, older lymphoma population has seen seven respiratory-related deaths along with five other serious adverse events, but so far Zynlonta has been deemed not related to the AEs.

Clinical trial
ADC Therapeutics halts Zynlonta study for safety issues, but other trials continue • Source: Shutterstock

ADC Therapeutics SA has voluntarily halted enrollment in a Phase II trial of its antibody-drug conjugate Zynlonta paired with rituximab due to seven respiratory event-related deaths and five other serious treatment-emergent adverse events (TEAEs), but the Swiss biopharma told Scrip it does not think this setback will impact the ongoing Phase III confirmatory trial of the ADC in relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Key Takeaways

  • Zynlonta, an antibody-drug conjugate, has US accelerated approval in third-line large B-cell lymphoma, but the trial deaths and adverse events occurred in a different patient population.

On 11 July, the Lausanne-headquartered firm reported that it has halted enrollment in the Phase II LOTIS-9 trial in unfit...

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