Incyte (NASDAQ:INCY) has announced the Phase 2 POD1UM-202 study result for the evaluation of retifanlimab, its PD-1 inhibitor in treating patients with advanced squamous cell carcinoma of the anal canal (SCAC) that after standard platinum-based chemo has progressed.
Retifanlimab well tolerated in subjects
The company enrolled 94 patients in the study, including those with well-controlled HIV infection (10%). Results indicated that retifanlimab monotherapy attained an objective response rate of around 14% as established through the independent central review using RECIST v1.1. The company observed the responses irrespective of the PD-L1 status, HIV+ status, age, or liver metastases presence. The PD-1 inhibitor was well tolerated with an expected safety profile of any PD-1 inhibitor without loss of HIV infection control.
Lance Leopold, the Group VP, Immuno-Oncology Development of the company, said that the POD1UM-202 study results show the potential of retifanlimab in providing meaningful treatment for SCAC patients that have progressed after standard-based chemo and this have a poor prognosis. He said that the trial data is very important, considering the study also enrolled HIV+ individuals at a higher risk of having SCAC and are usually systematically excluded from cancer clinical studies. Incyte presented the results during the 2020 European Society for Medical Oncology Virtual Congress.
SCAC common in people infected with HIV+ and HPV
According to Sheela Rao, a Consultant Medical Oncologist at The Royal Marsden H+NHS Foundation Trust, SCAC is a very rare cancer that shows increased incidence, especially in HIV+ patients, and thus presents a huge unmet medical need. Sheela added that the POD1UM-202 trial data was encouraging and supports additional investigation on retifanlimab’s potential as an alternative treatment for SCAC patients.
Mostly SCAC is linked with HIV and human papillomavirus (HPV) infections accounting for around 3% of digestive tract cancers. There is no currently available standard treatment for SCAC patients that have progressed following first-line chemotherapy, and such patients have poor 5-year survival.
The company is currently enrolling patients in POD1UM-303/InterAACT 2 Phase 3study of a combination of retifanlimab with carboplatin and paclitaxel in inoperable locally recurrent SCAC.