Blockbuster Bristol Myers Squibb cancer immunotherapy combines with experimental therapy from Nektar Therapeutics Failure A key test for melanoma has dealt a blow to a drug research alliance that began four years ago with a nearly $2 billion financial commitment from the pharma giant.
BMS said Monday that an independent data monitoring committee from the phase 3 study told the company that the drug combination fell short of two main goals: helping patients live longer without making their cancer worse, and showing improvement as measured by the proportion of patients. Complete or partial response to treatment. The committee also said that an interim analysis of the data showed that the drug combination was not statistically significant for overall survival, the study’s third primary endpoint.
Shares of Nektar opened Monday at $5 a share, down nearly 53% from Friday’s close. BMS shares were steady.
The BMS drug Opdivo is a checkpoint inhibitor, a drug that blocks proteins on immune cells so that they cannot recognize cancer cells. This approach doesn’t work for all patients, so BMS and other companies with checkpoint inhibitors have been testing various drug combinations to see if any of them could help expand the reach of the therapy to more people and More types of cancer.That’s the key driver BMS formed an alliance with Nektar in 2018 in a deal that paid the San Francisco-based biotech $1 billion in cash up frontIn addition, BMS purchased approximately $850 million worth of Nektar shares at $102.60 per share and agreed to pay up to $1.78 billion in milestone payments.
The deal requires the two companies to share the clinical development of the drug combination. When the agreement was announced, Stephen Doberstein, Nektar’s chief research and development officer, told MedCity News at the time that his company’s drug offered to convert cold tumors (meaning they don’t trigger a strong immune response) into triggering Sparks the potential of hot tumors. Strong immune cell activity.
“We may be able to offer the benefits of immunotherapy to the majority of patients who do not respond at all,” Doberstein said.
Nektar’s drug bempegaldesleukin is an engineered version of interleukin 2 (IL-2), a protein called a cytokine that stimulates a response from two types of immune cells, T cells and natural killer cells. Nektar’s drug is designed to selectively activate the IL-2 pathway in these immune cells without triggering the activity of regulatory T cells that suppress the immune response. Encouraging 2018 announcement of drug research partnerships result From a small Phase 1/2 dose-escalation study (38 patients) testing the drug combination in melanoma, renal cell carcinoma and non-small cell lung cancer.
The preliminary results, released Monday, came from a phase 3 study that enrolled 783 patients with advanced melanoma that had spread or could not be removed by surgery. Patients were randomly assigned to receive an infusion of BMS and Nektar, or BMS alone. BMS and Nektar said they would review data from the failed melanoma study and the results would be shared with the scientific community.
Since the drug combination showed no benefit compared to Opdivo alone, BMS and Nektar said they had decided to unblind the clinical trial. No additional analyses of clinical trial objectives for overall survival will be performed. The disappointing results also led the companies to discontinue participation in a separate open-label Phase 3 study evaluating the drug combination as an adjuvant, a treatment for preventing the recurrence of melanoma after surgical removal.
The bempegaldesleukin plus Opdivo drug pair is also being tested in separate clinical trials in kidney and bladder cancers. Those studies are continuing, BMS and Nektar said.
“While we are surprised and deeply disappointed by these results from the melanoma study, we continue to await preliminary results from our first two ongoing studies in renal cell carcinoma and urothelial carcinoma, currently expected in the first half of 2022. ,” Jonathan Zalevsky, chief research and development officer at Nektar Therapeutics, said in a prepared statement. “We look forward to working with BMS to evaluate data from these other studies to guide the future development of bempegaldesleukin.”
Public domain image courtesy of Julio C. Valencia National Cancer Institute
