In a recent breakthrough for cancer treatment, Retifanlimab-dlwr has been approved. It will now be used most often as the first-line therapy for patients with advanced anal cancer. This latest indication expands use of Retifanlimab-dlwr for combination treatment with carboplatin and paclitaxel. That comes on the heels of the 2023 advance approval for treatment of metastatic or recurrent locally advanced Merkel cell carcinoma.
The recent approval is based on the clinically meaningful results for the POD1UM-303/InterAACT 2 trial. This trial was to determine the efficacy of this combination therapy as compared to monotherapy. The trial included 308 chemotherapy-naive, inoperable subjects, including 21 patients with well-controlled HIV infection. As for primary outcomes, patients treated with Retifanlimab-dlwr had a median PFS of 9.3 months. In comparison, participants assigned to a placebo experienced a median PFS of just 7.4 months.
While the primary overall survival (OS) determination is still in progress, a recent interim analysis found positive outcomes. In the Retifanlimab-dlwr arm, median overall survival (OS) has only been reached recently at a robust 29.2 months. By comparison, the median OS for the placebo group was just 23 months. Importantly, of the patients who were randomized to placebo initially, 45% crossed over to Retifanlimab-dlwr after first experiencing disease progression.
Overall, these results are encouraging, but the trial emphasized safety issues. In one clinical trial, 47% of patients who got Retifanlimab-dlwr with chemotherapy had serious adverse reactions. Patients in the monotherapy study suffered serious reactions at a rate of 40%.
Its currently approved dose is 500 mg IV every four weeks. Patients are to stay on treatment until there is disease progression or intolerable toxicity. For example, the first-line treatment enjoys a maximum of 12 months, and the second indication 24 months.
The economic impact of this novel therapy is huge, given that a single 500 mg/20 mL dose costs $15,748.45. The POD1UM-202 trial was not intended to serve as an efficacy study, yet an overall response rate of 14% was observed. Participants enjoyed a median duration of response 9.5 months.
“This approval marks an important advancement as it makes a new treatment approach available for this challenging cancer,” said Marwan Fakih, emphasizing the significance of this development for patients battling advanced anal cancer.
Leave a Reply