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2018-11-06| R&DTrials & Approvals

Pembrolizumab Upstages Topline PD-1/L1 drugs in lung cancer tussle

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By Ajay V. Patil

First line combination and label update approval for Pembrolizumab
With latest approval of Pembrolizumab (Merck & Co.) in combination with chemotherapy, as a treatment for previously untreated squamous Non-Small Cell Lung Cancer (NSCLC) patients (irrespective of the PD-L1 expression level), it became the first member of the anti PD-1/PD-L1 class of drugs to win such approval (October 30, 2018). Besides this first line approval, US FDA also approved ‘label update’ for Pembrolizumab. Although, it is not the first time that it has edged over other promising nemeses like Nivolumab (AstraZeneca) and Atezolizumab (Roche) on the approval timeline.

Keynote-407
This approval was primarily based on the phase III trial, Keynote-407. In this clinical trial, regardless of tumor PD-L1 expression status, Pembrolizumab in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) markedly improved overall survival (OS), reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49, 0.85]; p=0.0017). This is yet another clinical milestone for this anti-PD1 antibody among numerous ongoing trials for various types of lung cancers (Keynote-407; squamous cell lung cancer) and (Keynote- 024,042,189; non-squamous cell lung cancer).

Reasoning dominance and the future prospects
One of the hurdles for comparing performance in this class of drugs is the use of different biomarkers for evaluation. Nonetheless, being the only player providing favorable ‘overall survival’ data gave Pembrolizumab edge over the competition. Persistent performance of Pembrolizumab in lung cancer can cement its position for other cancer indications. With Pembrolizumab’s dominance in lung cancer indication, it will be interesting to observe the competitive results by other big players for upcoming indications like renal cell carcinoma, breast cancer and bladder cancer.

References
1. https://www.fiercepharma.com/pharma/merck-beats-out-roche-yet-another- keytruda-lung-cancer-approval
2. https://www.mrknewsroom.com/news-release/oncology/fda-approves-mercks- keytruda-pembrolizumab combination-carboplatin-and-either-

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