Biotech Strategy Blog

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

Posts tagged ‘ESMO 2014 Pembrolizumab’

Madrid – it’s Day 2 of the European Society for Medical Oncology (Twitter #ESMO14) annual meeting and the Congress is now in full swing. Today one of the highlights is the Presidential Session that takes place this afternoon. It’s where all attendees have the opportunity to hear what ESMO think is the most noteworthy data at the meeting, irrespective of the type of cancer.

Yesterday, we launched our Live ESMO blog series for Day 1, with commentary and insights posted throughout the day. If you missed the afternoon and evening notes, you can check them out.

Meanwhile, we’re really looking forward to hearing the CLEOPATRA trial overall survival (OS) data in HER2+ metastatic breast cancer at 4pm CET this afternoon.

CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) is an international, Phase III, randomised, double-blind, placebo-controlled study. The study evaluated the efficacy and safety profile of pertuzumab (Perjeta) combined with trastuzumab (Herceptin) and docetaxel chemotherapy compared to trastuzumab and chemotherapy plus placebo in 808 women with previously untreated HER2-positive metastatic breast cancer (mBC) or with HER2-positive mBC that that had recurred after prior therapy in the adjuvant or neo-adjuvant setting.

Sally wrote on Pharma Strategy Blog about the PFS data for the trial which was first presented at the 2011 San Antonio Breast Cancer Symposium (SABCS).

As Sally noted back in 2011, “the idea behind combining pertuzumab (Perjeta) and trastuzumab upfront is to enable a more comprehensive shut down of the HER2 pathway and delay resistance setting in.”

We’re now looking forward to the final overall survival data that will be presented for the first time at a conference by Dr Sandra Swain (Washington DC) in the Presidential Session at ESMO this afternoon.

There’s a press briefing between 8 and 9 where this data will be featured, so expect news releases to follow soon after this. Out of respect to researchers and those who come to these meetings to hear the data, we typically don’t write about data until after it’s been presented, so expect our initial commentary and analysis to follow later in the day on the blog.

What else are we looking out for at the Congress today and which sessions will the Mav be in? Subscribers can login in to read more or you can sign up below.


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.

Subscribers can login below to read the next in our ESMO 2014 preview series on what’s hot in melanoma? If you don’t already have access to Premium Content (available only to subscribers) you can purchase access by clicking on the blue button below. Not only does your purchase give you access to future content for the time period selected, but also (at the moment) the back library of all the posts we’ve written to date, so if you missed the data at ASCO 2014, there’s still time to catch up.

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