Southern Cancer Center, P C

Pfizer has shared promising top-line results from a phase 3 study of sasanlimab as an induction therapy in a subset of bladder cancer patients. The phase 3 CREST trial has been evaluating the subcutaneously-administered investigational anti-PD-1 monoclonal antibody in combination with standard-of-care Bacillus Calmette-Guérin (BCG), with or without maintenance, in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). Approximately 10,500 people are diagnosed with bladder cancer in the UK every year and NMIBC, in which the cancer cells are confined to the inner lining of the bladder, accounts the majority of new cases. Despite induction therapy with BCG followed by maintenance, up to 50% of high-risk NMIBC patients experience disease recurrence and often require a radical cystectomy, which is associated with significant risks. CREST met its primary endpoint, with sasanlimab plus BCG demonstrating a clinically meaningful and statistically significant improvement in event-free survival compared to BCG alone. The overall safety profile of the combination was also shown to be generally consistent with the known profile of BCG and with data reported from clinical trials of sasanlimab, Pfizer said. “The initial therapy of high-risk, NMIBC with BCG has not advanced in decades,” said Roger Dansey, chief oncology officer at Pfizer. “[These] pivotal phase 3 CREST results are potentially practice-changing, representing the first advance in therapy for BCG-naïve, high-risk, non-muscle invasive cancer in over 30 years.” Pfizer said it is planning to discuss the results with global health authorities to support potential regulatory filings for sasanlimab in this indication, adding that it will continue to evaluate the drug in combination with its antibody drug conjugate portfolio in advanced solid tumours. The announcement comes three months after Pfizer and its Astellas-partnered Padcev (enfortumab vedotin) was approved by the Medicines and Healthcare products Regulatory Agency in combination with Merck & Co’s – known as MSD outside the US and Canada – Keytruda (pembrolizumab) to treat advanced bladder cancer. The antibody-drug conjugate/PD-1 inhibitor combination was specifically authorised by the UK regulator to treat unresectable or metastatic urothelial carcinoma in adults who are eligible for platinum-containing chemotherapy.