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FDA Grants Regular Approval for Pembrolizumab in Combination with Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

Approval is based on the results of KEYNOTE-189 study
04 Sep 2018
Thoracic Malignancies

On 20 August 2018, the US Food and Drug Administration (FDA) approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumour aberrations.

Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate (ORR) and progression-free survival (PFS) for patients randomised to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study.

The latest approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product. This action is based on the results of KEYNOTE-189 (NCT02578680), a randomised, multicentre, double-blind, active controlled study enrolling 616 patients receiving first-line treatment for metastatic non-squamous NSCLC. Patients were randomised (2:1) to receive pembrolizumab or placebo in combination with pemetrexed, and investigator’s choice of either cisplatin or carboplatin every 3 weeks for 4 cycles followed by pembrolizumab or placebo and pemetrexed. Treatment with pembrolizumab continued until disease progression, unacceptable toxicity, or a maximum of 24 months.

The primary efficacy outcome measures were overall survival (OS) and PFS, as assessed by a blinded independent committee review (RECIST v1.1.) 

The trial demonstrated a statistically significant improvement in OS for patients randomised to pembrolizumab and chemotherapy (HR 0.49; 95% CI: 0.38, 0.64; p < 0.00001) in a pre-specified interim analysis. The median OS was not reached at the time of the data cut-off in the pembrolizumab plus chemotherapy arm and was 11.3 months for those in the chemotherapy arm. The trial also demonstrated an improvement in PFS for patients randomised to pembrolizumab plus chemotherapy (HR 0.52; 95% CI: 0.43, 0.64; p < 0.00001). The median PFS was 8.8 months for patients receiving pembrolizumab plus chemotherapy and 4.9 months for those receiving chemotherapy alone. The ORR was significantly higher (48% vs. 19%; p = 0.0001) for those in the pembrolizumab plus chemotherapy arm and the median response duration was 11.2 months and 7.8 months, respectively.

The most common adverse reactions reported in ≥20% of patients in KEYNOTE-189 were fatigue/asthenia, nausea, constipation, diarrhoea, decreased appetite, rash, vomiting, cough, dyspnoea, and pyrexia.

The recommended pembrolizumab dose and schedule for non-squamous NSCLC is 200 mg as an intravenous infusion over 30 minutes every 3 weeks.

Full prescribing information for Keytruda is available here.

This is the second FDA approval using the Real Time Oncology Review pilot programme that enabled the FDA review team to begin analyzing data before the application submission.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

Last update: 04 Sep 2018

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