An early-stage trial has shown promising results for Bristol-Myers Squibb's Opdivo (nivolumab) in combination with Nektar Therapeutics' bempegaldesleukin for first-line treatment of urothelial carcinoma.
The combination showed signs of tumour reduction in patients with first-line advanced or metastatic urothelial carcinoma.
"Preliminary data from the ongoing PIVOT-02 trial in metastatic urothelial cancer patients demonstrated important response rates, including complete responses, in patients who were cisplatin-ineligible or refused standard of care," said Mary Tagliaferri, chief medical officer of Nektar Therapeutics.
”These responses were observed regardless of baseline PD-L1 expression and no relapses occurred. In this cohort of Stage IV bladder cancer patients with a median age of 70, the combination therapy was generally well tolerated with no Grade 4 or 5 adverse events reported," she added.
“Of note, our translational research demonstrated that in patients with the highest unmet medical need – those whose tumours did not express PD-L1 at their baseline scan – treatment with the combination resulted in 70% of patients converting to PD-L1 positive expressers. These data support our development strategy in this tumour setting, including the Phase 2 PIVOT-10 study underway in cisplatin-ineligible urothelial cancer patients with low PD-L1 tumour expression.”
In addition to urothelial carcinoma, the PIVOT-02 trial is also evaluating the combined therapy in melanoma, renal cell carcinoma, non-small-cell lung cancer or triple-negative breast cancer.