(Lung Cancer) Pembrolizumab + EP Chemotherapy: KEYNOTE-604 Trial Results
(Lung Cancer) Pembrolizumab + EP Chemotherapy: KEYNOTE-604 Trial Results
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(Lung Cancer) Pembrolizumab + EP Chemotherapy: KEYNOTE-604 Trial Results
- June 19, 2020
- 2 min read
From May 29-31, 2020, Charles M. Rudin presented at the ASCO 2020 Virtual Meeting the efficacy and safety results of anti-PD-1 antibody + EP therapy (cisplatin + etoposide) as first-line treatment for previously untreated extensive-stage small cell lung cancer patients in the KEYNOTE-604 Phase III clinical trial.
In the KEYNOTE-604 Phase III clinical trial, previously untreated extensive-stage small cell lung cancer patients (N=453) were randomized into the following two groups. The primary endpoints were overall survival and progression-free survival, and secondary endpoints included objective response rate, duration of response, and safety:
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anti-PD-1 antibody group (three-week cycles, anti-PD-1 antibody 200 mg for up to 35 cycles + EP therapy for up to 4 cycles, N=223).
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Placebo group (three-week cycles, placebo + EP therapy for up to 4 cycles, N=228).
The FDA has acknowledged the sustained anti-tumor effect of anti-PD-1 antibody anti-PD-1 antibody monotherapy after third-line treatment for metastatic extensive-stage small cell lung cancer. Therefore, this trial was designed to verify the utility of anti-PD-1 antibody as first-line treatment.
At a median follow-up of 13.5 months, the results showed that the primary endpoint median progression-free survival was 4.5 months for the anti-PD-1 antibody group / 4.3 months for the placebo group, demonstrating significant improvement. The median overall survival was 10.8 months for the anti-PD-1 antibody group / 9.7 months for the placebo group, which did not show significant improvement.
The secondary endpoint objective response rate was 71% for the anti-PD-1 antibody group / 62% for the placebo group. The median duration of response was 4.2 months for the anti-PD-1 antibody group / 3.7 months for the placebo group.
Regarding safety, the incidence of grade 3-4 adverse events was 77% for the anti-PD-1 antibody group / 75% for the placebo group. The incidence of grade 5 adverse events was 6% for the anti-PD-1 antibody group / 5% for the placebo group. The treatment discontinuation rate due to adverse events was 15% for the anti-PD-1 antibody group / 6% for the placebo group.
Based on the KEYNOTE-604 trial results, Charles M. Rudin concluded that anti-PD-1 antibody + EP therapy as first-line treatment for previously untreated extensive-stage small cell lung cancer patients improved progression-free survival and extended overall survival, with manageable tolerability, suggesting that adding anti-PD-1 antibody to standard treatment (EP therapy) may enhance therapeutic benefit.
[Disclaimer] The clinical trial data and pharmaceutical information translated by "Medical Supporter" from overseas studies are not intended to encourage participation in clinical trials or use of new drugs. The translated materials are for reference only and do not constitute medication guidelines. Please consult with healthcare professionals, and refer to the original text below for accurate content.
Source: KEYNOTE-604: Pembrolizumab (pembro) or placebo plus etoposide and platinum (EP) as first-line therapy for extensive-stage (ES) small-cell lung cancer (SCLC). (2020 ASCO Virtual Scientific Program, Abstract No: 9001)
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