Adding neoadjuvant nivolumab to chemo shows clear benefit in resectable non-small-cell lung cancer

Reuters Health - 19/04/2021 - Adding the immune-checkpoint inhibitor nivolumab to chemotherapy in the neoadjuvant setting improves outcomes of patients with resectable non-small-cell lung cancer (NSCLC), according to results of the CheckMate 816 trial.

"CheckMate 816 is the first phase-3 study to show the benefit of neoadjuvant immunotherapy plus chemo for resectable NSCLC," Dr. Patrick Forde said during a press briefing at the American Association for Cancer Research (AACR) virtual annual meeting.

"Nivolumab in combination with chemo could represent a potential new neoadjuvant option for these patients," said Dr. Forde, of the Sidney Kimmel Comprehensive Cancer Center and Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University in Baltimore, Maryland.

In CheckMate-816, adults with stage 1b-3a resectable NSCLC and no known activating alterations in the EGFR or ALK genes were randomly allocated to nivolumab plus platinum-doublet chemotherapy or chemotherapy alone (179 patients in each group), followed by surgery.

There was a statistically significant improvement in the primary endpoint of pathological complete response (pCR) with nivolumab plus chemotherapy versus chemotherapy alone (24% vs. 2%; odds ratio, 13.9; P<0.0001), Dr. Forde reported.

The improvement in pCR was consistent across all subgroups, including disease stage, NSCLC subtype, PD-L1 status, tumor mutational burden status, and for both men and women, he noted.

Adding nivolumab to chemotherapy also significantly increased the major pathological response rate to 36.9% compared to 8.9% with chemotherapy alone. Pre-surgery objective response rate on imaging was also higher in the nivolumab group (54% vs. 37%).

"The addition of neoadjuvant nivolumab to chemotherapy maintained a tolerable safety profile and did not impede the feasibility of surgery," Dr. Forde told the briefing.

Eighty-three percent of patients in the nivolumab-chemotherapy group went on to receive definitive surgery as did 75% of patients in the chemotherapy only group.

"Remarkably, despite the addition of nivolumab to neoadjuvant chemotherapy, there was no associated increase in treatment-related adverse events, and rates of adverse events leading to surgery delay or cancellation were low. This provides reassurance that side effects from the combination will not adversely impact patients' ability to have curative surgery," Dr. Forde said in the news release.

This study was sponsored by Bristol Myers Squibb, which markets nivolumab as Opdivo. Dr. Forde has served as an uncompensated consultant to the company in the past and the company has provided research funding to his institution.

SOURCE: https://bit.ly/3mFbWXK American Association for Cancer Research virtual annual meeting, held April 10-15, 2021.

By Megan Brooks



Posted on 19 April 202120 April 2021