FDA Approves Pembrolizumab for Small-Cell Lung Cancer

June 18, 2019
Erin Kayata

The FDA approved pembrolizumab as a treatment option for patients with metastatic small-cell lung cancer.

The Food and Drug Administration (FDA) announced that they recently approved pembrolizumab as a treatment for patients with metastatic small-cell lung cancer (SCLC), according to a press release.

“Small-cell lung cancer, which accounts for 10% to 15% of all lung cancers, is often diagnosed at an advanced stage where the prognosis is very poor and there have historically been limited treatment options,” said Dr. Patrick Ott, MD, PhD, clinical director, Center for Immuno-Oncology, Dana-Farber Cancer Institute in a press release from Merck. “The approval of KEYTRUDA in small-cell lung cancer provides an additional treatment option for patients based on the clinical response rates from KEYNOTE-158 and KEYNOTE-028.”

The approval was granted for patients who showed disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The drug was approved after being studied in 83 patients with SCLC with disease progression who were on or completed two or more prior lines of therapy. These patients were enrolled in one of two multicenter, multi-cohort, nonrandomized, open-label trials. They received either pembrolizumab 200 mg intravenously every 3 weeks (n = 64) or 10 mg/kg intravenously every 2 weeks (n = 19). Treatment continued until disease progression, unacceptable toxicity, or up until 24 months.

The main efficacy outcome was measured by overall response rate (ORR) and duration of response as assessed by a blind independent central review. The ORR was 19% (95% CI, 11%–29%); the complete response rate was 2%. Responses were durable for 6 months or longer in 94%, 12 months or longer in 63%, and 18 months or longer in 56% of the 16 responding patients.

Adverse reactions in patients who received single-agent pembrolizumab for previously treated SCLC were similar to those in patients with other solid tumors who received pembrolizumab. Common adverse reactions reported in at least 20% of patients included fatigue, decreased appetite, cough, nausea, and constipation. Pembrolizumab was discontinued for adverse reactions in 9% of patients, and 25% had at least one dose withheld for adverse reactions. Serious adverse reactions occurred in 31%. The most frequent (≥ 2%) serious adverse reactions were pneumonia and pleural effusion.

The recommended dose for SCLC is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

The Food and Drug Administration (FDA) announced that they recently approved pembrolizumab as a treatment for patients with metastatic small-cell lung cancer (SCLC), according to a press release.

“Small cell lung cancer, which accounts for 10% to 15% of all lung cancers, is often diagnosed at an advanced stage where the prognosis is very poor and there have historically been limited treatment options,” said Dr. Patrick Ott, MD, PhD, clinical director, Center for Immuno-Oncology, Dana-Farber Cancer Institute in a press release from Merck which makes KEYTRUDA (pembrolizumab). “The approval of KEYTRUDA in small cell lung cancer provides an additional treatment option for patients based on the clinical response rates from KEYNOTE-158 and KEYNOTE-028.”

The approval was granted for patients who showed disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The drug was approved after being studied in 83 patients with SCLC with disease progression who were on or completed two or more prior lines of therapy. These patients were enrolled in one of two multicenter, multi-cohort, nonrandomized, open-label trials. They received either pembrolizumab 200 mg intravenously every 3 weeks (n = 64) or 10 mg/kg intravenously every 2 weeks (n = 19). Treatment continued until disease progression, unacceptable toxicity, or up until 24 months.

The main efficacy outcome was measured by overall response rate (ORR) and duration of response as assessed by a blind independent central review. The ORR was 19% (95% CI, 11%–29%); the complete response rate was 2%. Responses were durable for 6 months or longer in 94%, 12 months or longer in 63%, and 18 months or longer in 56% of the 16 responding patients.

Adverse reactions in patients who received single-agent pembrolizumab for previously treated SCLC were similar to those in patients with other solid tumors who received pembrolizumab. Common adverse reactions reported in at least 20% of patients included fatigue, decreased appetite, cough, nausea, and constipation. Pembrolizumab was discontinued for adverse reactions in 9% of patients, and 25% had at least one dose withheld for adverse reactions. Serious adverse reactions occurred in 31%. The most frequent (≥ 2%) serious adverse reactions were pneumonia and pleural effusion.

The recommended dose for SCLC is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

"Though any new drug approvals for patients with SCLC is welcome news, it should be noted that this trial included patients who are checkpoint inhibitors (CPI) naive and only had chemotherapy," said Vamsi Velcheti, MD, FACP, FCCP, medical director of the thoracic oncology program at NYU Langone Perlmutter Cancer Center in New York City. "With recent approval of atezolizumab in combination with platinum-etoposide followed by maintenance atezolizumab for 1 year, most patients with SCLC receive CPI in the frontline. Hence, the impact of the new approval of pembrolizumab in patients with SCLC will be minimal.”

Pembrolizumab was also recently approved by the FDA as a treatment for head and neck squamous cell carcinoma.

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