Long-Term Follow-Up Shows Keytruda Continues to Improve Survival in Patients With PD-L1–Positive Advanced NSCLC

Keytruda (pembrolizumab) continued to demonstrate a clinically meaningful improvement in overall and progression-free survival, compared with docetaxel, in patients with previously treated, PD-L1–positive advanced non-small cell lung cancer (NSCLC) after more than five years of follow-up, according to results from the phase 2/3 KEYNOTE-010 study presented at the 2020 World Conference on Lung Cancer.

In the KEYNOTE-010 trial, treatment with Keytruda significantly improved overall survival (the period of time patients on a trial are still alive after they are diagnosed or started treatment) and progression-free survival (the time from treatment to disease progression or worsening). In the five-year follow-up, the agent continued to significantly improve overall and progression-free survival, compared with docetaxel, in patients with a PD-L1 Tumor Proportion Score (TPS) of 50% or greater and a PD-L1 TPS of 1% or greater.

“Pembrolizumab monotherapy is a standard of care in patients with immunotherapy-naive or previously treated, PD-L1–positive advanced non-small cell lung cancer,” Dr. Roy S. Herbst, chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital, and associate cancer center director for translational research at Yale Cancer Center, said during a virtual presentation of the follow-up results.

In the trial, patients were randomized to receive either 2 mg/kg or 10 mg/kg of Keytruda every three weeks (690 patients), or 75 mg/m2 docetaxel every three weeks (343 patients). In the follow-up analysis, the study authors aimed to evaluate long-term overall and progression-free survival.

In the follow-up, treatment with Keytruda continued for 35 cycles, or approximately two years, or until disease progression or unacceptable toxicity. The analysis included patients who completed Keytruda treatment or stopped treatment after experiencing a complete response. In addition, patients who received Keytruda for six months or more could also receive a second course with the drug for up to one year after their disease progressed when they stopped their initial treatment.

The five-year median overall survival rates more than doubled with Keytruda, compared with docetaxel, in patients with a PD-L1 TPS of 50% or greater (25% versus 8.2%, respectively) and in patients with a PD-L1 TPS of 1% or greater (15.6% vs 6.5%). Median overall survival was also superior with Keytruda in patients with a PD-L1 TPS of 50% or greater (16.9 months versus 8.2 months) and a PD-L1 TPS of 1% (11.8 months versus 8.4 months), compared with docetaxel. Median progression-free survival rates were also superior for those with a PD-L1 TPS of 50% or greater (5.3 months versus 4.2 months) and 1% or greater (4 months versus 4.1 months).

In addition, patients who completed 35 cycles of Keytruda treatment demonstrated durable clinical benefit, with an overall response rate of 98.7%, which included 15 complete responses and 63 partial responses. In total, 61 patients (77.2%) were alive at the data cutoff, including 38 patients who were alive without progressive disease.

Lastly, 21 patients received a second course of Keytruda after their disease progressed following the first round of treatment. Among those patients, 15 (71.4%) were alive at data cutoff. The overall response rate after starting a second course of Keytruda was 52.4%, including one complete response, 10 partial responses and six patients had stable disease.

“We continue to see a clinically meaningful improvement in (overall survival) and (progression-free survival). Five-year rates more than doubled in the (Keytruda)-treated patients for overall survival, compared with those receiving docetaxel,” Herbst concluded. “Patients who completed 35 cycles, or two years, experienced durable responses. The second course of (Keytruda) provided meaningful disease control. Incidents of any grades 3 to 5 treatment effects were lower with (Keytruda) versus docetaxel.”

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