Read nextPembrolizumab improves survival in early-stage resectable lung cancer
Published by:
Click Here to Manage Email Alerts
Pembrolizumab as neoadjuvant and adjuvant therapy significantly extended OS among adults with resectable stage II, IIIA or IIIB non-small cell lung cancer, according to the agent’s manufacturer.
A second prespecified interim analysis from the randomized phase 3 KEYNOTE-671 trial showed no new safety issues associated with neoadjuvant and adjuvant use ofpembrolizumab (Keytruda, Merck)— a PD-1 inhibitor previously approved for multiple NSCLC indications.
“This is a significant milestone in the treatment of resectable non-small cell lung cancer, as it represents the first phase 3 study to show a statistically significant overall survival benefit for these patients with stage II, IIIA or IIIB non-small cell lung cancer,”马约莉绿色,医学博士senior vice president and head of late-stage oncology development at Merck Research Laboratories, said in a company-issued press release.
“These results build upon the previously reported event-free survival data, and demonstrate the potential for this KEYTRUDA-based regimen to help extend the lives of these patients,” Green added. “We're excited by the progress we have made to help patients with earlier stages of non-small cell lung cancer, who are in need of additional treatment options.”
The double-blind KEYNOTE-671 trial enrolled 786 adults with stage II, IIIA or IIIB resectable NSCLC.
Investigators randomly assigned study participants to receive either neoadjuvant pembrolizumab plus chemotherapy before surgery followed by adjuvant pembrolizumab or placebo plus neoadjuvant chemotherapy before surgery followed by adjuvant placebo.
The study met one of its dual primary endpoints by showing “statistically significant and clinically meaningful improvement in OS” among those who received neoadjuvant and adjuvant pembrolizumab compared with placebo, the release stated.
Results from the first interim analysis presented at this year’s ASCO Annual Meeting showed the study met its other dual primary endpoint, withpembrolizumab significantly extending EFSas neoadjuvant and adjuvant therapy compared with chemotherapy alone.
The manufacturer said full results from the second interim analysis will be presented later this month at the European Society for Medical Oncology Congress, in addition to being shared with regulatory authorities.
The FDA already accepted a supplemental biologics license application for the indication based on results from the KEYNOTE-671 trial and established a target action date of Oct. 16, 2023.
Read more about
Click Here to Manage Email Alerts
