Karen L. Reckamp, MD, spoke about safety signals that emerged in the Lung-MAP nonmatched phase 2 substudy S1800A and what the next steps are for the combination of ramucirumab/pembrolizumab in patients with non–small cell lung cancer pretreated with chemotherapy and immunotherapy
CancerNetwork® spoke with Karen L. Reckamp, MD, director of the Division of Medical Oncology and professor of Medicine at Cedar-Sinai Medical Center, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting about the Lung-MAP nonmatched phase 2 substudy S1800A (NCT03971474) in patients with advanced non–small cell lung cancer who were previously treated with immunotherapy and chemotherapy. Investigators set out to determine if ramucirumab (Cyramza) plus pembrolizumab (Keytruda) was superior to standard of care in this population, with a primary end point of overall survival (OS).
The median OS was 14.5 months (80% CI, 13.9-16.1) in the ramucirumab plus pembrolizumab arm vs 11.6 months (80% CI, 9.9-13.0) in the standard of care arm (HR, 0.69; 80% CI, 0.51-0.92; standard log-rank P = .05).
We found that by using a nonchemotherapeutic backbone there were more toxicities in the standard-of-care arm [with] chemotherapy. As we use ramucirumab, we were concerned about vascular toxicity and did see some increase in grade 3 vascular toxicities. These were also seen in the docetaxel plus ramucirumab [arm]. We saw more immune-related adverse events, as you might expect, about 30% of grade 3/4 events [with ramucirumab/pembrolizumab].
We’re excited about these data. This is a randomized phase 2 trial and it shows a robust survival benefit [of ramucirumab/pembrolizumab in this setting]. Obviously, this is a smaller trial and should be confirmed in a larger, randomized phase 3 trial. These are both approved agents, so there may be some benefit to patients thinking about Compendia Listing and potentially moving on to a phase 3 trial that may confirm the results.
Reckamp KL. Overall survival from a phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for advanced non–small cell lung cancer previously treated with immunotherapy: Lung-MAP nonmatched substudy S1800A. J Clin Oncol. 2022;40(suppl 16):9004. doi:10.1200/JCO.2022.40.16_suppl.9004