Phase 3 CheckMate -73L of Nivolumab/Ipilimumab in NSCLC Misses PFS End Point
Nivolumab with ipilimumab did not lead to progression-free survival benefits in patients with unresectable stage III non-small cell lung cancer, missing the primary end point of the CheckMate -73L study.
Holographic concept of lung cancer: © catalin - stock.adobe.com
The experimental regimen of the phase 3 CheckMate -73L study (NCT04026412) investigating nivolumab (Opdivo) and ipilimumab (Yervoy) for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) did not improve progression-free survival (PFS), missing the primary end point of the study.1
“Unfortunately, adding immunotherapy concurrently with definitive chemoradiation did not improve PFS outcomes in this setting,” said Joseph Fiore, vice president, global program lead, thoracic cancers, Bristol Myers Squibb, in a 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.”
A full evaluation of the data will be completed and shared with the scientific community at a later date.
Regarding safety, the adverse events observed were in line with previous reports and known profiles of the agents.
In CheckMate -73L, 925 patients with unresectable stage III NSCLC were randomized to receive nivolumab plus concurrent chemoradiotherapy followed by nivolumab plus ipilimumab or nivolumab monotherapy vs concurrent chemoradiotherapy followed by durvalumab (Imfinzi). Along with the primary end point of PFS, secondary end points included overall survival, objective response rate, time to response, and duration of response.1,2
To be eligible for enrollment, patients were required to have an ECOG status of 1 or lower and newly diagnosed, treatment-naive stage IIIA, IIIB, or IIIC pathologically confirmed NSCLC. Patients were not eligible for study participation if they had an active infection requiring systemic treatment within 14 days of randomization, a history of organ or tissue transplant requiring systemic use of immune suppression agents, or had previously received prior thoracic radiotherapy.2
The combination of nivolumab and ipilimumab is currently indicated for the first-line treatment of patients with metastatic NSCLC with tumors expressing PD-L1 without EGFR or ALK aberrations. The combination plus 2 cycles of platinum doublet chemotherapy is also indicated for frontline treatment of patients with metastatic or recurrent NSCLC without EGFR or ALK aberrations.1
REFERENCES:
1. Bristol Myers Squibb provides update on phase 3 CheckMate -73L trial. News release. Bristol Myers Squibb. May 10, 2024. Accessed May 13, 2024. https://tinyurl.com/429nenbb
2. A study of nivolumab and ipilimumab in untreated participants with stage 3 non-small cell cung cancer (NSCLC) that is unable or not planned to be removed by surgery (CheckMate73L). ClinicalTrials.gov. Updated January 28, 2024. Accessed May 13, 2024. https://clinicaltrials.gov/study/NCT04026412
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