Misako Nagasaka, MD
The invited discussant of the ORIENT-11 trial, Misako Nagasaka, MD, a medical oncologist at Karmanos Cancer Institute, Wayne State University, Detroit, noted that, if approved, sintilimab will join a crowded list of first-line immuno-oncology agents for advanced non–small cell lung cancer, including pembrolizumab, atezolizumab, and nivolumab plus ipilimumab. “Recent approvals have complicated the treatment landscape, but it’s always great to have multiple options,” said Dr. Nagasaka.
ORIENT-11 vs KEYNOTE-189
According to Dr. Nagasaka, the ORIENT-11 trial is of “high importance” because it provides data for a checkpoint inhibitor plus chemotherapy combination in an East Asian population. This is in contrast to the KEYNOTE-189 trial of pembrolizumab plus platinum/pemetrexed, which had only a small number of patients from East Asia.
With identical hazard ratios, data from both studies are comparable, said Dr. Nagasaka, but the data from ORIENT-11 are not mature, with just 8.9 months of median follow-up versus 23.1 months with the KEYNOTE-189 trial. Given the favorable comparison with other immuno-oncology agents, providers must decide which outcome measures are most critical when choosing a regimen.
Words of Caution
“Perhaps you’d like to use something with the best response rate, or maybe you’re sticking to a single immuno-oncology agent because the toxicity profile is more favorable. Then again, perhaps you’re convinced by progression-free and overall survival data,” said Dr. Nagasaka. For now, though, providers should wait for longer follow-up before considering sintilimab plus platinum/pemetrexted, she added.
“The benefit seen in progression-free survival is certainly encouraging, but we have seen studies with progression-free survival improvement that did not translate to overall survival improvement,” Dr. Nagasaka cautioned. “Longer follow-up would allow events to mature, and we will ultimately see whether there will be a significant overall survival benefit.”
DISCLOSURE: Dr. Nagasaka has served as a consultant for Caris Life Sciences; has served on the advisory board of AstraZeneca, Daiichi Sankyo, Takeda, Novartis, and EMD Serono; and has received travel support from Heart Therapeutics.
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