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ASCO: Merck’s anti-PD1 impresses in skin and lung cancer

Promising MK-3475 immunotherapy to be known as pembrolizumab
Merck and Co - US headquarters

New data on Merck & Co's recently-filed anti-PD1 drug pembrolizumab (MK-3475) suggest the drug could be a 'paradigm shift' in the treatment of melanoma, according to clinical investigators.

The results of a 411-patient phase 1b study presented this week at the American Society of Clinical Oncology (ASCO) conference in Chicago showed that 69 per cent of pembrolizumab-treated individuals were still alive at one year.

The impressive survival rate was achieved even though more than half the patients in the study were in the most advanced stages of melanoma and 77 per cent had been treated with other drugs, including Bristol-Myers Squibb's Yervoy (ipilimumab), which has rapidly emerged as the standard therapy for the skin cancer as it was the first to extend survival.

Overall, 34 per cent of patients experienced tumour response, including 40 per cent of patients not previously treated with ipilimumab and 28 per cent of those whose disease progressed on prior ipilimumab.

Dr David Chao, a consultant medical oncologist at Royal Free Hampstead NHS Trust in the UK, said that the drug is "firmly helping to establish immunotherapy as one of the most exciting and promising treatment modalities in recent years."

Merck filed for approval of pembrolizumab in January and is hopeful for approval by the end of the year. The drug was awarded breakthrough status by the US FDA for melanoma and analysts have suggested that it could achieve multi-billion dollar annual sales at peak if it is approved in multiple cancer indications.

To that end, Merck also presented data on pembrolizumab in previously-untreated patients with advanced non-small cell lung cancer (NSCLC) at ASCO which showed the drug achieved an overall response rate of 47 per cent. It was also able to shrink tumours in 80 per cent of patients whose cancer tested positive for the PD-L1 gene mutation.

Based on the encouraging early date, Merck now says it is starting a phase III trial of pembrolizumab versus platinum-based chemotherapy as a first-line treatment for PD-L1-positive, advanced NSCLC.

In February 2014, Merck formed collaborations with Pfizer, Amgen and Incyte to explore the use of pembrolizumab in combination with other drugs across a variety of tumour types, including melanoma, renal cell carcinoma, NSCLC and breast cancer.

Pembrolizumab is in a race to market with other candidates in the PD-1/PD-L1 inhibitor drug class, including BMS' nivolumab and Roche's MPDL3280A, which both feature in trial presentations at ASCO across a range of cancer indications.

Article by
Phil Taylor

3rd June 2014

From: Research



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