Bristol Myers’s Hirawat on Pipeline Progress, Clinical Trial Diversity

development teams are working from home during the pandemic.

“Like most companies, we did experience a slight slowdown in the beginning of the pandemic in our clinical trial enrollments but we have seen a nice recovery that has started in the third quarter of this year as many of the countries – especially on the European side and the Asian side – as they started to recover,” he said.

CEO Giovanni Caforio noted during Bristol’s second quarter earnings call last month that clinical trial enrollment is beginning to resume in regions where studies were on hold and scientists are returning to the company’s labs, but remote working continues for many employees. (Also see “Bristol’s Opdivo Continues Slide, But First-Line Lung Offers Optimism” – Scrip, 6 Aug, 2020.)

“We took a proactive action of putting our cell therapy trials on hold in the early part of the pandemic because we knew that the health care system was inundated with a high rate of COVID infections and we knew that ICUs and emergency rooms have the infrastructure that was being were overwhelmed,” he added. “Because of that, we took a short hiatus, but then we reopened the trials as the pandemic was evolving and we learned where the sites could be reopened.”

New Opdivo data in early cancer treatment settings are among key upcoming milestones for Bristol’s R&D group, including results early next year from a Phase II/III clinical trial testing the PD-1 inhibitor in combination with the anti-LAG3 antibody relatlimab in first-line treatment of melanoma. The company reported preclinical results in 2017 showing the potential for a LAG3-targeting therapy to boost Opdivo’s efficacy. (Also see “Bristol’s Strong SITC: IDO, 1L Kidney Cancer And New Mechanism Data Bode Well” – Scrip, 13 Nov, 2017.)

Also, the first Phase III data in psoriasis for the TYK2 inhibitor BMS-986165 are expected in the fourth quarter of 2020 and first quarter of 2021 – a highly anticipated readout following the oral drug’s positive Phase II results in 2018. (Also see “Bristol Engineers An Oral TYK2 Inhibitor With Biologic-Like Efficacy That Rivals JAK Safety” – Scrip, 12 Sep, 2018.)

In hematology, BMS has multiple programs in protein homeostasis and protein degradation with clinical trials ongoing for the cereblon modulators iberdomide (CC-220) and CC-92480 that are being tested in multiple myeloma – programs the company gained through its acquisition of Celgene. (Also see “BMS/Celgene Post-Merger Early R&D Strategy: Partnerships Are Still Key, Vessey Says” – Scrip, 6 Feb, 2020.) Bristol is also gearing up for additional data from its T-cell engagers, including CC-93269 for multiple myeloma. (Also see “Bispecifics Could Be A Threat To CAR-Ts, But Efficacy May Trump Convenience” – Scrip, 19 Dec, 2019.)

In gastroenterology, BMS is planning to start the Phase III program for its interleukin-13 (IL-13)-targeting antibody cendakimab in eosinophilic esophagitis.

And in cardiovascular diseases, the company is building on its experience with the Pfizer Inc.-partnered coagulation factor Xa inhibitor Eliquis (apixaban). The factor XIa inhibitor BMS-986177 is in Phase II development under a collaboration with Janssen Pharmaceutical Cos. for a next-generation anticoagulant.

ENSURING MORE DIVERSE TRIALS

With so many programs in the clinic, BMS has dozens of opportunities to pursue its plans to make its clinical trials more inclusive of all the different patients it serves. The company and its Bristol Myers Squibb Foundation said in August that they would commit $300m to address health disparities, increase clinical trial diversity, increase spending with diverse suppliers and continue to increase African-American and Hispanic representation at all levels of the company.

“While our company has had a long history of addressing health disparities as part of the overall mission to serve the patients, we recognize the urgent need now to do more to address these serious gaps, which have become even more apparent as this pandemic struck,” Hirawat said.

As part of the company’s recent financial commitment to diversity and inclusion initiatives, “we are extending the reach of our clinical trials into underserved patient communities in the urban and rural US geographies. In addition, the foundation will – working in concert with organizations outside as well as academic centers – be developing a curriculum to train 250 new racially and ethnically diverse clinical investigators who will have mentorship and training opportunities.”

Ultimately, the goal is for these newly trained clinical trial investigators to enroll patients from their communities into clinical trials.

“We cannot let where people live dictate whether they have access to clinical trials or not, so we have to do more and we are committed to that,” Hirawat said.

BMS and other biopharma companies must become more involved in ensuring that there’s education and trust-building within diverse patient communities while training the next generation of clinical trial investigators from racially and ethnically diverse communities to help with those efforts, he noted.

“It is not something that only one company or only one segment of the industry can do,” Hirawat said. “It has to be a collaborative effort at every level and from all segments – from regulatory to academic to researchers as well as the companies – we all have to work together.”

This article was first published Sept. 24, 2020 in Scrip.

Image: iStock/Kubra Cavus