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BMS plugs on with Opdivo plus Yervoy in first-line NSCLC

Could be an alternative treatment option to chemotherapy


Bristol-Myers Squibb isn’t giving up on its aspiration for Opdivo in first-line non-small cell lung cancer (NSCLC), a category currently dominated by rival checkpoint inhibitor Keytruda from Merck/MSD. 

At the ESMO conference in Barcelona over the weekend BMS reported an overall survival (OS) benefit for PD-1 inhibitor Opdivo (nivolumab) plus low-dose CTLA-4 inhibitor Yervoy (ipilimumab) compared to chemotherapy in the CheckMate-227 study.

It’s hoping to convince oncologists that a double cancer immunotherapy approach could be a better option than Keytruda plus chemo, which is widely prescribed for newly-diagnosed NSCLC.

In the study, patients taking the Opdivo-Yervoy combination lived for a median 17.1 months compared with 14.9 months for those on chemo, reducing the risk of death by 21%.

At the two-year timepoint, 40% of the double immunotherapy group were still alive, regardless of their PD-L1 biomarker status. In the chemo group, 33% of PD-L1-positive patients were alive at two years, with 23% of PD-L1-negative patients reaching that milestone.

Lead author Solange Peters of the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, said at ESMO that BMS’ combination is a new, chemotherapy-sparing first-line option for NSCLC that “in my opinion…could be practice changing”.

“The important step now is to develop an algorithm to select the best front-line treatment for each patient,” she added. “We need to wait for a little more time to see which treatment really gives rise to improved long-term survival.”

Five-year survival data will uncover whether some options are better than others, along with toxicity data, continued Peters, noting that the low-dose of Yervoy used in CheckMate-227 had “a low rate of discontinuation and treatment-related toxicities or deaths” and was “highly manageable”.

One big limitation of the trial however is that it did not include a checkpoint inhibitor plus chemo group, which would have allowed it to make a comparison with what has become the standard-of-care for newly-diagnosed NSCLC, because it started before that was established.

“We don’t yet know if the findings are practice changing,” commented Marina Chiara Garassino of the Fondazione IRCCS Istituto Nazionale dei Tumori in Italy during an ESMO conference to discuss the findings.

“We need to understand which treatment is best for each patient: chemotherapy plus immunotherapy, immunotherapy alone, or immunotherapy plus immunotherapy.”

For now, BMS could be able to position Opdivo-Yervoy as an alternative option for patients unwilling or unable to go down the chemotherapy route.

“These results build upon the long-term clinical data in first-line melanoma and renal cell carcinoma demonstrating the benefit of combining Yervoy and Opdivo compared to standard of care," said BMS’ head of oncology development Fouad Namouni.

“We look forward to sharing these data with regulatory authorities,” he added.

Article by
Phil Taylor

30th September 2019

From: Research



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