Phase 3 trial of nivolumab for advanced lung cancer misses primary endpoint
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A randomized phase 3 trial that evaluated nivolumab with concurrent chemoradiotherapy for certain patients with advanced lung cancer failed to meet its primary endpoint, according to the agent’s manufacturer.
Nivolumab (Opdivo, Bristol Myers Squibb) is a PD-1 immune checkpoint inhibitor.
The agent is approved in the United States for several oncology indications, including treatment of certain patients with NSCLC, melanoma, renal cell carcinoma or classical Hodgkin lymphoma.
The CheckMate -73L trial included 925 patients with previously untreated, locally advanced stage III NSCLC who were not intended or eligible for curative surgery.
Researchers assigned patients to one of three regimens. Those in Arm A received nivolumab with concurrent chemoradiotherapy, followed by nivolumab plus ipilimumab (Yervoy, Bristol Myers Squibb). Those in Arm B received nivolumab with concurrent chemoradiotherapy followed by nivolumab monotherapy. Those in Arm C received concurrent chemoradiotherapy followed by durvalumab (Imfinzi, AstraZeneca).
PFS by blinded independent central review in Arm A vs. Arm C served as the primary endpoint. Secondary endpoints included OS, PFS by blinded review across study arms, objective response rate, time to response and duration of response.
“Unfortunately, adding immunotherapy concurrently with definitive chemoradiation did not improve PFS outcomes in this setting,” Joseph Fiore, PharmD, vice president and global program lead for thoracic cancers at Bristol Myers Squibb, said in a company press release. “There remains a critical need to improve long-term outcomes for these patients and we believe these results will help inform future drug development efforts in this setting.”
Adverse events observed among patients in Arm A appeared generally consistent with the known profiles of each component of the regimen, according to the release.
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