US-based pharmaceutical company Pfizer has reported positive results from a Phase III trial of sasanlimab and Bacillus Calmette-Guérin (BCG) for treating non-muscle invasive bladder cancer (NMIBC).
Data from the CREST trial showed that the combination therapy improved event-free survival (EFS) in BCG-naïve high-risk NMIBC patients compared to subjects who were only given BCG, meeting the trial’s primary endpoint.
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The open-label, three-parallel-arm trial is intended to assess the combination as an induction therapy with or without maintenance in this patient group.
It involved subjects receiving 300mg of sasanlimab via subcutaneous injection every four weeks, combined with BCG induction therapy, with or without maintenance.
Results from the trial showed a 32% decrease in the risk of disease-related events, including high-grade disease progression or recurrence, with the combination regimen versus standard of care treatment alone.
Median EFS has not yet been reached, while pre-specified subgroup analyses have shown consistent benefits across individuals with higher-risk disease, including those with T1 and carcinoma in situ (CIS) disease.
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By GlobalDataPfizer has reported that the combination therapy’s safety profile matches the known profiles of BCG and PD-1 inhibitors.
The company has shared these findings with worldwide regulatory bodies in preparation for filing regulatory applications for the therapy.
Pfizer oncology interim chief development officer Megan O’Meara said: “Today’s pivotal Phase III CREST results offer a much-needed therapeutic breakthrough and spotlight sasanlimab as the first immunotherapy combination with BCG to significantly improve outcomes for patients with BCG-naïve, high-risk NMIBC in over three decades.
“The CREST findings are especially impactful for these patients with early-stage cancer who may benefit the most from innovative treatment regimens, including a subcutaneous immune checkpoint inhibitor, that delay disease recurrence or progression.
“We look forward to working with global regulatory authorities to potentially bring sasanlimab as an important new treatment option to patients with high-risk NMIBC.”
