April 13 Quick Takes: AZ’s Phase III of Tagrisso unblinded early; plus BeiGene’s tislelizumab and Fennec’s Pedmark

‘Overwhelming efficacy’ for Tagrisso in NSCLC
AstraZeneca plc (LSE:AZN; NYSE:AZN) said an IDMC recommended the Phase III ADAURA trial of Tagrisso osimertinib to treat early-stage EGFR-mutated non-small cell lung cancer be unblinded early due to “overwhelming efficacy.” The compound is an oral irreversible inhibitor of EGFR-activating mutations and the T790M EGFR resistance mutation. Tagrisso is approved in some first- and second-line NSCLC settings.

A second approval, upbeat data for BeiGene’s anti-PD-1
BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160) said China’s National Medical Products Administration (NMPA) approved tislelizumab to treat locally advanced or metastatic urothelial carcinoma in patients with high PD-L1 expression who progressed on platinum-containing chemotherapy. This is the anti-PD-1 mAb’s second approved indication following a December approval in classical Hodgkin’s lymphoma. The company also said tislelizumab plus chemotherapy met the primary endpoint of improving progression-free survival in the Phase III BGB-A317-304 trial to treat first-line non-squamous NSCLC...