Sunday, December 3, 2023

Bristol Myers Squibb Wins FDA Approval for Lung Cancer Drug From $4B Deal – MedCity News

Immunotherapy is finding use in more cancers and as an earlier line of cancer treatment, as Bristol Myers Squibb knows well with its three FDA-approved checkpoint inhibitors. But for some cancers, a targeted therapy remains the first choice. The latest BMS approval is for a drug targeted to a particular genetic mutation already addressed by drugs from Pfizer and Roche. But BMS believes its new drug is a superior option.

The FDA has approved BMS’s repotrectinib as a treatment for non-small cell lung cancer (NSCLC) driven by mutations to the ROS1 gene. The pharmaceutical giant will market its new pill under the name Augtyro.

When the ROS1 gene fuses with another gene, the resulting mutation drives the abnormal cell growth characteristic of cancer. While NSCLC is the most common type of lung cancer, ROS1 mutations are rare, found in 1- 2% of NSCLC cases, according to the American Lung Association.

That 1-2% of patients in the most common type of lung cancer represents a large number of patients, said Nick Botwood, BMS’s senior vice president of oncology medical, speaking in an interview during the annual meeting of the American Society of Clinical Oncology in June. He added that ROS1-driven cancers are more prevalent in younger people, women, and non-smokers, and these cases can be particularly aggressive. In about 30% of ROS1-driven lung cancers, the disease spreads to the central nervous system (CNS), Botwood said. That brain metastasis occurs in about 50% of patients whose ROS1-driven cancer has relapsed or has not responded to an earlier treatment.

“[Augtryo ] has potential to be best in class, because we’re seeing really durable responses, particularly in patients who have CNS metastases,” Botwood said.

Augtyro is a small molecule designed to block enzymes that stem from mutated ROS1 to drive the hyperactive cell growth in cancer. Pfizer’s Xalkori and Roche’s Rozlytrek are also ROS1 inhibitors. Unlike those ROS1-targeting drugs, Augtyro is designed to fit tightly in the binding pocket of the mutation, enabling the drug to circumvent the resistance that can develop with other ROS1 inhibitors, Botwood said.

Augtyro came from Turning Point Pharmaceuticals, a company that developed targeted therapies addressing genetic drivers of cancer. Last year, BMS paid $4.1 billion to acquire San Diego-based Turning Point. The company’s pipeline also included molecules addressing other genetic signatures.

FDA approval of Augtyro covers patients who have already been treated with a ROS1 inhibitor as well as those who haven’t yet received such therapies. The decision is based on results from a single-arm, open-label study that included 71 patients who had received up to one prior line of chemotherapy and/or immunotherapy, but not a ROS1 targeted therapy. Another group enrolled 56 patients who had received one prior ROS1 inhibitor and no prior chemotherapy or immunotherapy.

In the group naïve to ROS1 inhibitors, the overall response rate was 79% and the median duration of response was 34.1 months. In those previously treated with a ROS1-targeted therapy, the overall response rate was 38%; the median duration of response was 14.8 months. The most common adverse reactions reported included dizziness, a foul taste in the mouth, peripheral neuropathy, constipation, and breathing difficulty.

In a note sent to investors Thursday, William Blair analyst Matt Phipps wrote that Augtyro’s efficacy and duration of response support its use as a front-line therapy. But he added that physicians must consider the higher risk of dizziness that comes with the drug. Another factor that could affect commercialization of the new BMS product is greater physician familiarity with the already established Pfizer and Roche products. But there’s still opportunity for differentiation.

“Augtyro has also shown efficacy in patients previously treated with ROS1 TKI inhibitors or with known resistance mutations to these therapies, and therefore this could provide additional opportunity beyond the first-line setting,” Phipps said.

BMS believes the differentiating factors warrant premium pricing. The drug will cost about $29,000 a month, which is about 40% more than the ROS1 inhibitors from Pfizer and Roche. William Blair projects the drug could reach $258 million in sales by 2027, assuming the drug also receives European approval next year.

Photo: Mohammed Haneefa Nizamudeen, Getty Images

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