Merck and Daiichi Sankyo's HER3 antibody-drug conjugate reported a positive phase 3 result in EGFR-mutated lung cancer. Merck and Eisai's Keytruda-Lenvima combo delivered a win in liver cancer. An FDA document details shortfalls at a Granules plant in India. Plus more.
1. Merck, Daiichi rack up phase 3 ADC lung cancer win but report 2 deaths, immature OS data
Merck and Daiichi Sankyo’s HER3 antibody-drug conjugate patritumab deruxtecan reported a positive phase 3 trial in EGFR-mutated non-small cell lung cancer following previous treatment with EGFR tyrosine kinase inhibitor. While progression-free survival was significantly longer in the ADC group than in the chemotherapy arm, overall survival data remained immature. Two deaths were chalked up to interstitial lung disease.
A combination of Merck’s Keytruda and Eisai-partnered Lenvima significantly reduced the risk of disease progression or death by 34% when added to transarterial chemoembolization in intermediate-stage liver cancer in the phase 3 LEAP-012 trial. The positive readout came after the Keytruda-Lenvima combo failed to outperform Lenvima alone in advanced liver cancer in the LEAP-002 trial.
3. Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection
The FDA recently slapped Granules with a Form 483 reprimand. During an inspection of the firm’s Telangana facility in India last year, FDA staffers saw trucks carrying torn and crumpled materials attempting to leave the plant, according to the document. In these scraps, the FDA found signed manufacturing documents, handwritten worksheets and a large number of uncontrolled papers.
Astellas and Daiichi Sankyo are among drugmakers that have delivered some of the highest benefit approvals in the past four years, according to a Harvard University study using a scoring system by the European Society of Medical Oncology. Astellas benefited from its Pfizer-partnered Padcev in bladder cancer, and Daiichi from its AstraZeneca-partnered Enhertu in breast cancer.
5. ESMO: Innovent links cytokine fusion protein to responses in colorectal cancer
Innovent Biologics shared promising data for its PD-1/IL-2 bispecific, IBI363, in colorectal cancer, reporting a 22% response rate from its combination with Avastin in 32 patients with microsatellite stable or mismatch repair proficient tumors. The median duration of response and progression-free survival were 8.1 months and 4.1 months, respectively.
Other News of Note
6. ESMO: AZ, Daiichi build case for Enhertu in breast cancer patients with brain metastases