Orpathys plus Tagrisso shows survival benefit in lung cancer

China's IIT system faces scrutiny after undisclosed gene therapy deaths. AstraZeneca and Daiichi Sankyo's Enhertu showed promise in lung cancer trials. Tanabe Pharma to receive $435M for global rights to dermatology drug. Sandoz partners with Shanghai Henlius for biosimilars. Other biotech news includes CAR-T trial deaths, SK's settlement, and Hengrui's profit squeeze.

AstraZeneca halted the Phase III eVOLVE-Lung02 trial for volrustomig after an IDMC review found the drug unlikely to meet primary endpoints of PFS or OS in PD-L1 negative NSCLC patients. The company stated no new safety concerns were identified. AstraZeneca continues other Phase III trials for volrustomig in different cancer types. The setback follows other recent pipeline disappointments, but the company reported positive results in two other late-stage lung cancer studies.

AstraZeneca halted the phase 3 eVOLVE-Lung02 trial of volrustomig for first-line metastatic NSCLC, as it is unlikely to meet primary endpoints. The trial compared volrustomig plus chemotherapy against pembrolizumab plus chemotherapy in patients with low PD-L1 expression. AstraZeneca will continue other trials for volrustomig in different cancers.

AstraZeneca (AZN) is halting the eVOLVE-Lung02 Phase III trial of volrustomig plus chemotherapy in metastatic non-small cell lung cancer (mNSCLC) after the Independent Data Monitoring Committee concluded the treatment was unlikely to meet primary endpoints of progression-free survival or overall survival in patients with PD-L1 negative tumors. The decision was based on a planned review of trial data, and the safety profile was consistent with known profiles. AstraZeneca will continue other Phase

Phase 3 SAFFRON trial data reported that osimertinib 80 mg daily plus investigational savolitinib 300 mg twice daily improved progression-free survival and overall survival versus doublet platinum chemotherapy in EGFR-mutated, MET-overexpressed/amplified NSCLC after progression on osimertinib. Safety matched known profiles. AstraZeneca and Hutchmed said full results will be presented later.

Daiichi Sankyo and AstraZeneca reported phase 3 DESTINY-Lung04 topline results. In 454 treatment-naive patients with HER2 exon 19/20 mutant advanced nonsquamous NSCLC, trastuzumab deruxtecan (Enhertu) 5.4 mg/kg improved progression-free survival versus SOC (platinum-pemetrexed plus pembrolizumab). The trial is ongoing for secondary endpoints including overall survival.