Bristol Myers Cuts Off Allergy Asset In Spite of Phase 3 Victory

Bristol Myers Squibb has persisted with its aggressive cost-reduction strategy, abandoning plans to market a competitor to Dupixent despite achieving its phase 3 objectives and halting development on a potential successor to Sotyktu.

The firm has discontinued many internal and partnered initiatives since Chris Boerner, Ph.D., assumed the role of CEO. Boerner originally aimed for $1.5 billion in savings. Amid the ongoing cost-reduction initiative, the CEO increased the target by an additional $2 billion this week. BMS aims to achieve savings by establishing a higher threshold for investments.

Cendakimab did not meet the required standards. The antibody targets IL-13, an interleukin addressed by Regeneron and Sanofi’s Dupixent. Last year, BMS announced that a phase 3 study for eosinophilic esophagitis achieved both co-primary outcomes, enabling the pharmaceutical company to compete with Dupixent and Takeda’s Eohilia on the market.

However, BMS discreetly pulled cendakimab from its portfolio in the fourth-quarter release. Adam Lenkowsky, Chief Commercialization Officer at BMS, discussed the withdrawal on an earnings call with investors on Thursday.

“Given the data that we have seen, we’ve made the decision not to commercialize cendakimab,” Lenkowsky stated. “We’re going to continue to prioritize investments and opportunities where we have a competitive advantage. We can deliver the highest return for the company in areas where we believe that we have an opportunity to deliver potentially transformational outcomes for patients.”

BMS made the choice to invest in TYK2 based on similar reasoning. The company concluded a phase 2 study of its second-generation TYK2 inhibitor BMS-986322 for psoriasis in August. The drug candidate remains in BMS’ pipeline; nevertheless, an analyst raised concerns over the lack of progression after the completion of the phase 2 study, prompting Samit Hirawat, M.D., who heads development at BMS, to shed light on the reasons behind the program’s stagnation.

Hirawat explained that the company needs to determine the areas within its pipeline to concentrate on and set priorities accordingly. Currently, the primary focus is on Sotyktu, aiming to maximize its potential from both development and commercial standpoints, which is why TYK2 is not under development at this time.

BMS is advancing in other domains, accelerating the expected results from a phase 3 trial of iberdomide in multiple myeloma by including minimum residual disease (MRD) as a co-primary outcome. Hirawat said that BMS engaged in discussions on the change with the FDA and would consult with regulators once it has findings to confirm their interpretation of the data and any other requirements they may have. Continued use of MRD is anticipated.

Hirawat noted the necessity for updated endpoints, mentioning that the company is actively assessing the possibility of using an earlier MRD endpoint readout to expedite the development of its multiple myeloma assets. However, he emphasized that this approach would depend on factors such as timing, patient populations, and the rate of event accumulation.