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Zynlonta

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Zynlonta safety concerns rise as LOTIS-5 shows higher deaths
healthcare6 hours ago

Zynlonta safety concerns rise as LOTIS-5 shows higher deaths

ADC Therapeutics’ LOTIS-5 phase 3 trial in relapsed/refractory DLBCL shows Zynlonta plus Rituxan improving progression-free survival (6.1 vs 4.7 months) and complete response rate (39.5% vs 26.7%), but with more deaths (27/440, 13.2% vs 9/440, 4.6%) and higher serious adverse events, driven largely by older patients and potentially influenced by longer monitoring in the treatment arm. There was no detrimental effect on overall survival. The safety signal spurred a roughly 52% drop in the company’s stock; ADC says it will meet with the FDA in August and plans to submit for full approval in Q4, with Zynlonta remaining the company’s sole marketed product.

via Fierce Pharma|
#adverse-events#diffuse-large-b-cell-lymphoma#healthcare
Zynlonta safety signal triggers death spike in confirmatory trial, sending ADC Therapeutics shares tumbling
business9 hours ago

Zynlonta safety signal triggers death spike in confirmatory trial, sending ADC Therapeutics shares tumbling

In the LOTIS-5 Phase 3 trial for relapsed/refractory DLBCL, Zynlonta plus rituximab showed a higher death count (27) versus 9 in the control arm among 440 patients, with deaths characterized as treatment-emergent events and not definitively linked to the drug; safety concerns contributed to a more than 50% drop in ADC Therapeutics’ stock to about $1.44, even as the study met its primary endpoint of improved progression-free survival. There was no clear overall survival benefit, though higher response rates were reported. The company said it will discuss a path forward with the FDA and plans a supplemental filing for full approval in Q4.

via BioSpace|
#adc-therapeutics#business#clinical-trial-lotis-5