Clinical Roundup

Rybrevant drug combo demonstrates durable PFS in second-line EGFR-mutated NSCLC in CHRYSALIS-2 cohort

Follow-up results from the phase Ib/II CHRYSALIS-2 study cohort evaluating the safety and tolerability of the combination of Rybrevant (amivantamab-vmjw)—a bispecific antibody targeting epidermal growth factor receptor and mesenchymal-epithelial transition—with lazertinib, an oral third-generation EGFR tyrosine kinase inhibitor, plus platinum-based chemotherapy (carboplatin and pemetrexed) in patients with relapsed/refractory non-small cell lung cancer and EGFR mutations, showed that the drug combination led to durable progression-free survival. 
Clinical Roundup

Datopotamab deruxtecan improves PFS in advanced NSCLC, phase III trial shows

Positive high-level results from the TROPION-Lung01 phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer treated with at least one prior therapy.
Clinical Roundup

Preliminary results from phase I show safety and tolerability of Reqorsa + Tagrisso in NSCLC

Preliminary results from eight patients in the phase I portion of the Acclaim-1 clinical study evaluating Reqorsa immunogene therapy (quaratusugene ozeplasmid) with Tagrisso (osimertinib) in patients with advanced, EGFR mutant non-small cell lung cancer whose disease progressed after Tagrisso showed that Reqorsa was generally well tolerated, as there were no dose limiting toxicities. Promising efficacy results were also observed.
Drugs & Targets

FDA grants priority review to repotrectinib for locally advanced or metastatic ROS1-positive NSCLC

FDA accepted the New Drug Application for repotrectinib, a next-generation tyrosine kinase inhibitor, for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer based on results from the phase I/II TRIDENT-1 trial. FDA granted the application priority review and assigned a Prescription Drug User Fee Act goal date of November 27.