Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘Nivolumab vs Pembrolizumab’

Yesterday’s biotech and pharmaceutical industry news was dominated by the FDA approval of PD-1 inhibitor pembrolizumab (Keytruda) from Merck for the treatment of advanced or unresectable melanoma in patients who no longer respond to other drugs (FDA announcement). Approval was widely expected after the compelling data presented at ASCO 2014 for both pembrolizumab, and another PD-1 checkpoint inhibitor, nivolumab (Opdivo), which was was approved in July in Japan for sale by Ono Pharmaceuticals, a partner of Bristol-Myers Squibb (BMS).

It was amusing to see some of the Academic thought leader reactions to the branding of these drugs:

Not sure if Master Yoda would approve of the names, but no one can doubt that the companies in this space are executing and getting it done expeditiously!   We’ve written extensively about the potential of PD-1/PD-L1 inhibitors from quite a few meeting over the last couple of years so it is good to see them market it market. Melanoma is certainly an area where there is a lot happening in immuno-oncology, and the standard of care will likely be changed by these new agents as they gain approval earlier in the disease and optimal combination strategies are developed that shift the survival curves not only to the right, but also upwards.

BMS recently announced that they had stopped their phase 3 clinical trial of nivolumab first-line clinical trial in untreated BRAF wild type melanoma early in June (press release).  It’s good news for patients with advanced melanoma that there are now new treatment options that will help them live considerably longer.  Skin cancer rates are going up unfortunately, with a third more hospital admissions in the UK over the past five years, which experts believe is down to foreign holidays and the use of sunbeds in tanning salons (BBC Health story).

I expect we’ll hear a lot of excitement at the forthcoming European Society of Medical Oncology (ESMO) meeting in Madrid about what’s happening in immuno-oncology, along with concerns about how countries will afford these new life-saving medicines.

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Melanoma oral abstracts at ASCO 2014The melanoma oral abstracts session at ASCO 2014 was packed as a full house in the Arie Crown lecture theatre listened to the latest on new immuno-oncology therapies that are leading a revolution in melanoma treatment.

In the Clinical Science Symposium on PD-1 blockade and in the oral session at ASCO 2013 we heard how PD-1 antibodies nivolumab, MK-3475 (now pembrolizumab) and the PD-L1 antibody MPDL3280A had high response rates, long durations of response with favourable toxicity. This led to melanoma suddenly becoming one of the hottest areas of cancer drug development.

Global incidence of stage III melanoma continues to rise, with a high 5 year relapse rate (89% in stage IIIc), so there remains a need for more effective treatment options. It’s particularly sad to see so many young people end up with metastatic melanoma from over-exposure to tanning beds or too much sun! After going to several melanoma sessions, I don’t go out as much in the mid-day sun here in Florida.

So what did latest data show at ASCO 2014? Is pembrolizumab better than nivolumab? Will combinations be more effective than single agent therapies alone and will toxicities impact the risk:benefit profile?

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