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(NSCLC), with no EGFR or ALK genomic tumor aberrations.
The checkpoint inhibitor was previously approved for patients with metastatic nonsquamous NSCLC in 2017, under the accelerated approval process, based on phase 2 results. Approval is now converted to a full approval, based on the results of the phase 3 Keynote-189 trial.
Patients in Keynote-189 who received pembrolizumab in combination with pemetrexed and platinum chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (hazard ratio, 0.49 [95% confidence interval, 0.38-0.64]; P less than .00001), according to the company press statement.
There was also a significant improvement in progression-free survival (PFS) with the pembrolizumab plus chemotherapy combination, compared with chemotherapy alone (HR, 0.52 [95% CI, 0.43-0.64]; P less than .00001).
Patients with metastatic NSCLC, regardless of PD-L1 tumor expression status and with no EGFR or ALK genomic tumor aberrations were randomized to receive pembrolizumab 200 mg, cisplatin or carboplatin, and pemetrexed intravenously every 3 weeks for four cycles followed by pembrolizumab 200 mg for up to 24 months and pemetrexed every 3 weeks (n = 410); or cisplatin or carboplatin and pemetrexed intravenously every 3 weeks for four cycles followed by pemetrexed every 3 weeks (n = 206). Treatment continued until progression of disease or unacceptable toxicity.
The most common adverse reactions with pembrolizumab, resulting in discontinuation, were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions or laboratory abnormalities resulting in interruption of treatment were neutropenia (13%), asthenia/fatigue (7%), anemia (7%), and thrombocytopenia (5%).
(NSCLC), with no EGFR or ALK genomic tumor aberrations.
The checkpoint inhibitor was previously approved for patients with metastatic nonsquamous NSCLC in 2017, under the accelerated approval process, based on phase 2 results. Approval is now converted to a full approval, based on the results of the phase 3 Keynote-189 trial.
Patients in Keynote-189 who received pembrolizumab in combination with pemetrexed and platinum chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (hazard ratio, 0.49 [95% confidence interval, 0.38-0.64]; P less than .00001), according to the company press statement.
There was also a significant improvement in progression-free survival (PFS) with the pembrolizumab plus chemotherapy combination, compared with chemotherapy alone (HR, 0.52 [95% CI, 0.43-0.64]; P less than .00001).
Patients with metastatic NSCLC, regardless of PD-L1 tumor expression status and with no EGFR or ALK genomic tumor aberrations were randomized to receive pembrolizumab 200 mg, cisplatin or carboplatin, and pemetrexed intravenously every 3 weeks for four cycles followed by pembrolizumab 200 mg for up to 24 months and pemetrexed every 3 weeks (n = 410); or cisplatin or carboplatin and pemetrexed intravenously every 3 weeks for four cycles followed by pemetrexed every 3 weeks (n = 206). Treatment continued until progression of disease or unacceptable toxicity.
The most common adverse reactions with pembrolizumab, resulting in discontinuation, were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions or laboratory abnormalities resulting in interruption of treatment were neutropenia (13%), asthenia/fatigue (7%), anemia (7%), and thrombocytopenia (5%).
(NSCLC), with no EGFR or ALK genomic tumor aberrations.
The checkpoint inhibitor was previously approved for patients with metastatic nonsquamous NSCLC in 2017, under the accelerated approval process, based on phase 2 results. Approval is now converted to a full approval, based on the results of the phase 3 Keynote-189 trial.
Patients in Keynote-189 who received pembrolizumab in combination with pemetrexed and platinum chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (hazard ratio, 0.49 [95% confidence interval, 0.38-0.64]; P less than .00001), according to the company press statement.
There was also a significant improvement in progression-free survival (PFS) with the pembrolizumab plus chemotherapy combination, compared with chemotherapy alone (HR, 0.52 [95% CI, 0.43-0.64]; P less than .00001).
Patients with metastatic NSCLC, regardless of PD-L1 tumor expression status and with no EGFR or ALK genomic tumor aberrations were randomized to receive pembrolizumab 200 mg, cisplatin or carboplatin, and pemetrexed intravenously every 3 weeks for four cycles followed by pembrolizumab 200 mg for up to 24 months and pemetrexed every 3 weeks (n = 410); or cisplatin or carboplatin and pemetrexed intravenously every 3 weeks for four cycles followed by pemetrexed every 3 weeks (n = 206). Treatment continued until progression of disease or unacceptable toxicity.
The most common adverse reactions with pembrolizumab, resulting in discontinuation, were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions or laboratory abnormalities resulting in interruption of treatment were neutropenia (13%), asthenia/fatigue (7%), anemia (7%), and thrombocytopenia (5%).