Clinical Trials Come to a ‘Disappointing’ End When Drug Combo Fails to Improve Outcomes in Kidney and Bladder Cancer

The clinical development of BEMPEG plus Opdivo will end after clinical trials showed that the drug combination did not lead to significant improvements in outcomes in patients with kidney or bladder cancer.

Bristol Myers Squibb and Nektar Therapeutics recently announced that the two companies have stopped plans to develop a treatment regimen that combined BEMPEG (bempegaldesleukin) with Opdivo (nivolumab) for patients with kidney cancer and bladder cancer.

The announcement comes after two clinical trials — the phase 3 PIVOT-09 and the phase 2 PIVOT-10 — did not meet their goals for improved outcomes in patients with kidney cancer and bladder cancer, respectively. Other trials that were assessing the drug combination will also be halted.

“Disappointing to see the entire BEMPEG (plus) Opdivo program shut down,” Dr. Rana R. McKay, a urogenital medical oncologist and associate professor of Medicine at UC San Diego Health in La Jolla, California, wrote on Twitter. “Many studies across multiple solid tumors from melanoma, bladder, RCC all failed to meet primary endpoint. Lots of resources expended. Need to redefine early no-go decisions.”

PIVOT-09 was a international trial comparing BEMPEG plus Opdivo to a tyrosine kinase inhibitor (TKI) drug in patients with previously untreated advanced renal cell carcinoma (kidney cancer). Of the 623 patients who were enrolled, half received the drug combination, while another received Sutent (sunitinib) or Cabometyx (cabozantinib).

Patients given BEMPEG and Opdivo did not have a statistically significant improvement in objective response rate, which indicates that that the disease shrunk as a result of treatment, compared to those who received a TKI therapy. Researchers also found that there was no significant difference in overall survival between the two groups as well.

Similarly, in the phase 2 PIVOT-10 trial of BEMPEG plus Opdivo in patients with PD-L1—low, cisplatin-ineligible advanced bladder cancer, the drug pair did not prove to be efficacious enough to warrant the continuation of its development.

Other BEMPEG-Opdivo trials that will end include a study in muscle-invasive bladder cancer known as CO045-009; a phase 1/2 study in recurrent and/or refractory childhood cancer (CA045-020); and a phase 1/2 study of BEMPEG, Opdivo and a TKI treatment in kidney cancer (CA045-011).

Patients who are enrolled in these clinical trials should discuss standard of care treatment options with their clinicians, according to a press release from Bristol Myers Squibb.

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