Karen L. Reckamp, MD, discusses the key findings of the phase 2 Lung-MAP substudy S1800A for patients with stage IV, previously-treated non–small cell lung cancer.
Karen L. Reckamp, MD, director, Medical Oncology, associate director, Clinical Research, and Medical Oncology director, Lung Institute at Samuel Oschin Cancer Center, discusses the key findings of the phase 2 Lung-MAP substudy S1800A (NCT03971474) for patients with stage IV, previously-treated non–small cell lung cancer (NSCLC).
The randomized study evaluated the combination of pembrolizumab (Keytruda) and ramucirumab (Cyramza) in patients with NSCLC who had acquired resistance to immune checkpoint inhibitors (ICI). In the study, acquired resistance was defined as previous ICI therapy for at least 84 days with progressive disease on or after therapy.
According to Keckamp, the primary end point was overall survival (OS) and an improvement of OS was seen when compared with the standard of care (SOC) consisting of ramucirumab and docetaxel. The median OS observed with ramucirumab/pembrolizumab was 15.0 (95% CI, 13.2-17) compared with 11.6 months (95% CI, 8.5-13.8) with SOC (HR, 0.61; 95% CI, 0.38-0.97; 1-sided P =0.019).
0:08 | The primary end point was overall survival. We had 136 patients randomized, and we found an improved overall survival in the ramucirumab and pembrolizumab arm, with a median overall survival of 14.5 months vs 11.6 months in those who receive standard of care. I think importantly, in the standard of care arm, 2/3 of the patients did receive docetaxel/ramucirumab as the most potent combination that we have at this time and as a standard of care for patients who have had tumor growth on both immunotherapy and chemotherapy in the past.
0:47 | We evaluated the outcomes of overall survival by PD-L1 status, and there was no difference based on PD-L1 status, there was benefit for all patients receiving ramucirumab/pembrolizumab. By performance status, we did see a trend toward increased benefit in those patients who had squamous cell or mixed histology. But again, there was a benefit across all subgroups.