Please login to the form below

Not currently logged in
Email:
Password:

BMS hails Opdivo and Yervoy combo in melanoma

New PD-1 therapy shines against the world’s first immunotherapy for skin cancer

BMS HQCombining Bristol-Myers Squibb's PD-1 inhibitor Opdivo and older melanoma drug Yervoy boosted progression-free survival (PFS) compared to Yervoy alone in a clinical trial.

The data - reported at the American Association of Cancer Research (AACR) meeting in Philadelphia - showed that the combination achieved an objective response rate (ORR) of 61% compared to 11% for Yervoy alone when given to previously-untreated patients with advanced (stage III or IV) melanoma

That looks encouraging given trials of Opdivo (nivolumab) as a monotherapy in this patient group revealed an ORR of around 40%, although different trial designs clearly mean no direct comparison can be made.

Giving Opdivo alongside anti–CTLA-4 antibody Yervoy (ipilimumab) resulted in a complete response in 22% of patients, while PFS was increased by 60% and - at the time of reporting - had still not reached a median after 11 months of follow-up.

Michael Giordano, head of oncology development at BMS, said the "results reinforce our belief that the future lies in the combination of immuno-oncology agents".

CTLA-4 and PD-1 exert their effects through complementary mechanisms and in preclinical models inhibiting both seems to have a synergistic improvement on anti-tumour activity.

The results have also been published in the New England Journal of Medicine (NEJM), with the authors concluding that the combination "resulted in durable responses and a substantially higher objective response rate, longer progression-free survival, and higher rates of complete response than ipilimumab monotherapy."

Yervoy quickly established itself as one of the cornerstones of melanoma therapy after launch and achieved sales of $1.3bn last year, and the new add to the body of evidence suggesting Opdivo should be used earlier in therapy than at present.

At the moment Opdivo - along with rival drug Keytruda (pembrolizumab) from Merck & Co - are approved as second-line agents for melanoma after treatment with Yervoy or a BRAF inhibitor such as Roche's Zelboraf (vemurafenib) and GlaxoSmithKline's Tafinlar (dabrafenib) if the patient's tumour is BRAF V600 mutation positive. 

Like Opdivo, Keytruda has also shown superiority to Yervoy in a head-to-head clinical comparison also reported in the NEJM this week.  

Moreover, both drugs were endorsed as first-line treatments by the National Comprehensive Cancer Network in the US - which means that insurers will likely reimburse them in this setting even ahead of formal approval of first-line use, and there is already evidence of off-label use in combination with Yervoy.

ISI Evercore analyst Mark Schoenenbaum said in a research note that the combination of Opdivo and Yervoy is likely to become the standard of care for first-line melanoma therapy. Further insights into the benefits of combining the two drugs will come with the results of the phase II CheckMate-067 study, which is due to complete in September 2016.


Article by
Phil Taylor

21st April 2015

From: Research

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Just::Health Communications

Just:: is a different kind of healthcare communications agency. Since 2006, we’ve been collaborating with clients around the world to...

Latest intelligence

Australian Flu and the dilemma of naming diseases
...
Wearables and Healthcare
What place do wearables have in affecting actual patient health outcomes and can they contribute to the NHS’s sustainability agenda? Or are they just the latest fad?...
What does a future-proof rep look like?
Businesses can no longer afford to push ahead with the traditional Key Account Management model....

Infographics