Biotech Strategy Blog

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

Posts tagged ‘Pembrolizumab Melanoma’

With the news hot off the press at the 2015 annual meeting of the American Association for Cancer Research (AACR) that Merck’s pembrolizumab (Keytruda) beat out BMS’s ipilimumab (Yervoy) in advanced melanoma, quite a few readers wrote in asking whether this signals the end for ipilimumab?

The short answer is no, and here’s why…

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Philadelphia – the 2015 annual meeting of the American Association for Cancer Research (AACR) is in full swing, with over 18,000 attendees, it’s probably the world’s largest meeting dedicated to cancer research. The theme is “Bringing Cancer Discoveries to Patients.”

AACR 2015 Annual Meeting Philadelphia

I challenge anyone not to attend, and come away inspired with new ideas on how the field of cancer research will evolve in coming years.

At this year’s annual meeting, not surprisingly, cancer immunotherapy is one of the hot topics. Yesterday there was the simultaneous publication of two papers in the New England Journal of Medicine (NEJM) to coincide with data presented at the meeting.

Pembrolizumab (Keytruda)  for the Treatment of Non–Small-Cell Lung Cancer

The conclusion of the paper by Edward B. Garon, MD (UCLA) et al was that:

Pembrolizumab had an acceptable side-effect profile and showed antitumor activity in patients with advanced non–small-cell lung cancer. PD-L1 expression in at least 50% of tumor cells correlated with improved efficacy of pembrolizumab.

The other paper published in the NEJM was for:

Pembrolizumab (Keytruda) versus Ipilimumab (Opdivo) in advanced Melanoma.

The conclusion of the paper by Caroline Robert, MD PhD, presented at AACR by Antoni Ribas, M.D., Ph.D.(UCLA) was:

The anti–PD-1 antibody pembrolizumab prolonged progression-free survival and overall survival and had less high-grade toxicity than did ipilimumab in patients with advanced melanoma.

AACR 2015 Press Briefing with Dr Topalian, Dr Ribas, Dr Garon

Dr Ribas (left) and Dr Garon (right) are pictured at an AACR media briefing chaired by Dr Suzanne Topalian (Johns Hopkins).

This year’s AACR annual meeting is to paraphrase Bertrand Tombal, “a Grand Cru year”. Not only in cancer immunotherapy, but in metabolism, epigenetics and advances in drug discovery.

We’re excited about the prospect of another three days at the meeting, but in the meantime in this post there’s some top-line thoughts for subscribers on some of the data that caught our attention over the weekend.

In recognition of AACR, there’s $50 off a quarterly subscription if you wish to purchase access (offer valid only during the week of the meeting – ends this Friday!)  If you’ve been sitting on the fence for a while wanting to try out BSB, now is a good opportunity to dip your toes in the water.

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Recently, Merck have been on a roll in the immuno-oncology space, with the announcement that their anti-PD–1 antibody, pembrolizumab (Keytruda), beat out BMS’s anti-CTLA4 antibody, ipilimumab (Yervoy) in a Phase 3 head-to-head frontline trial in metastatic melanoma. The two primary endpoints of OS and PFS were met and the trial will therefore be stopped early based on the IDMC recommendation. No further details are available until the presentation.

merck_logoThe data from the KEYNOTE–006 study is being presented at the annual American Association for Cancer Research (AACR) next month in the opening plenary session by Dr Antoni Ribas (UCLA).

While it’s nice to see evidence that one checkpoint inhibitor is potentially superior to another, in the long run, combinations are likely to be the best way forward.  This approach is more likely to yield improved responses in immunogenic tumours, but also to make non-immunogenic tumours more responsive, thereby improving patient outcomes further.

This begs the all important question – what hints from new emerging data can we glean that will help us figure out novel combination approaches with checkpoint inhibitors?

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Immuno-oncology is one of the hottest topics, if not, the hottest in cancer drug development at the moment, and every conference seems to advance the field forward. The pace of progress is breathtaking as thought leaders and pharma & biotech seek to maximize how to leverage the body’s immune system in the fight against cancer. It’s exciting times!

Coming up next on the calendar are two cancer conferences, the Society for Immunotherapy of Cancer (SITC) held in Maryland later this week, followed swiftly by the EORTC-AACR-NCI Molecular Targets conference (often referred to as the Triple meeting by industry insiders) in Barcelona just before Thanksgiving.

SITC 2014 Immunotherapy Banner

Whoa, that’s a lot of data yet to come, and then in December we have the American Society of Hematology (ASH) and San Antonio Breast Cancer Symposium (SABCS).

Back home in the Blighty, November is often referred to as the ‘month of the drowned dog’ because it rains a lot… at this rate it’s more like raining data – let’s hope not too many agents are headed for dog drug heaven! The good news for subscribers is there’s a lot of conference coverage to come!

2014 ESMO Congress Poster HallSo here we are, after nearly two dozen posts, it’s time to close out the 2014 ESMO coverage with a final review of the immuno-oncology posters that piqued our interest.

There were 16 in all that fitted that category. Normally, we highlight three or four gems from the poster halls, so more than a baker’s dozen is quite a feast.

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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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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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