Cabozantinib plus metronomic temozolomide showed a 15% response rate and 28.5-month median progression-free survival in a phase 2 NET study. A separate analysis found cabozantinib cost-effective for pancreatic NETs, but not extrapancreatic NETs, in China and the U.S.
Genmab is moving GEN1106, a SLITRK6-targeting ADC acquired through its $1.8bn ProfoundBio takeover, into phase 1 trials despite several recent discontinuations and the 2017 failure of the only other similar project.
Phase 2 trial of amivantamab in recurrent/metastatic adenoid cystic carcinoma achieved 72.2% clinical benefit rate with good tolerability. Combination therapy with pembrolizumab is being evaluated in head and neck squamous cell cancer.
The FDA has approved a once-monthly dosing schedule for subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) combined with lazertinib for first-line treatment of EGFR-mutated advanced NSCLC, based on PALOMA-2 trial data showing comparable efficacy to biweekly dosing.
The U.S. FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as monotherapy for adults with advanced head and neck squamous cell carcinoma, based on Phase 1b/2 study data showing rapid and durable responses.
The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.