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BMS CEO tackles investor ‘frustrations’ on immuno-oncology

Company faces pressure from competitors in renal cell carcinoma

Bristol-Myers Squibb chief executive Giovani Caforio barely mentioned the company’s finances on its third-quarter results call before launching into a defence of its immuno-oncology franchise, which has come under increasing pressure of late.

BMS was the pathfinder for the checkpoint inhibitor market with its CTLA4 inhibitor Yervoy (ipilimumab) and PD-1 blocker Opdivo (nivolumab), However, it has since lost ground to rival Merck & Co/MSD, whose PD-1 drug Keytruda (pembrolizumab) outsold Opdivo for the second quarter in a row, thanks to dominance in the big lung cancer market.

Opdivo is still no laggard, rising 42% to $1.79bn in the quarter, but is gradually being left in the rearview mirror by Keytruda which grew 80% to $1.89bn in the same period. Two-thirds of Keytruda’s sales come from non-small cell lung cancer (NSCLC), an indication in which Opdivo lost ground after a failed monotherapy trial in the first-line setting, and it’s being trying to recover with trials of Opdivo and Yervoy in combination.

Giovanni Caforio

Giovani Caforio

That effort came under pressure after regulators on both side of the Atlantic asked for more data on the filing which has pushed the review into next year. And in the meantime, Opdivo/Yervoy’s lucrative position in first-line kidney cancer is also under threat, with new data at ESMO on Keytruda and Merck KGaA’s PD-L1 inhibitor Bavencio (avelumab) – both given in tandem with Pfizer’s tyrosine kinase inhibitor Inlyta (axitinib) – leading to them being touted as a potential new treatment standard for these patients.

Caforio told analysts on the conference call that he is “aware of some of the frustration that many of you have”, but added: “based on the strong trends through three quarters, we continue to believe that Opdivo will grow in 2019 based on the current set of indications today.”

He started his defence by tackling reservations about the use of the tumour mutational burden (TMB) biomarker that was used in the Checkmate-227 trial of Opdivo/Yervoy in NSCLC, and is an attempt to carve out a niche in the first-line setting. Some analysts have suggested the survival rates for high- and low-TMB patients seemed similar in the study, raising questions about whether a regulator would approve a TMB-focused indication.

“We have always said this was going to be a complex review, and … we remain committed to working with health authorities on the application,” insisted Caforio, adding that other companies and academic institutions are also working on the biomarker.

Later on in the call however, Caforio stressed that while the company is incorporating TMB as an endpoint in other studies – including CheckMate 9LA of Opdivo/Yervoy plus chemotherapy in first-line NSCLC – “you shouldn't be thinking about that as being a primary endpoint in future studies. It's one of the areas we are exploring.”

BMS’ CEO also tackled the first-line kidney cancer threat, saying: “I feel very good about our market position.” He pointed out that BMS’ was the first company to have an immuno-oncology therapy approved for renal cell carcinoma (RCC) and has been “calling on physicians who treat renal cancer for almost three years.”

Opdivo and Yervoy is currently the go-to second-line treatment for RCC in most major markets, added Christopher Boerner, BMS’ newly appointed chief commercial officer, who said the combination already has a market share of around 30-35% in first-line RCC just a few weeks after approval, and more than 50% share in second-line.

“With comparison to the data that we saw at ESMO, we continue to believe that Opdivo plus Yervoy has a very competitive profile,” said Boerner. “We're compelling on overall survival, we're compelling on complete response rates and we're compelling with respect to the safety profile and quality of life.”

Overall, BMS reported an 8% increase in revenues to $5.7bn, with gains for Opdivo and Yervoy (up 18% to $382m) accompanied by a good performance from antiplatelet drug Eliquis (apixaban) which grew 28% to $1.58bn.

BMS also highlighted new data with BMS’ selective TYK2 inhibitor for moderate to severe plaque psoriasis, which has moved into phase 3 and is also in mid-stage testing for Crohn's disease, ulcerative colitis and lupus. The company said the oral drug could rival the efficacy of injectable antibodies for psoriasis, and also have a better safety profile than other oral agents such as the JAK inhibitors.

Article by
Phil Taylor

26th October 2018

From: Marketing



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