News|Articles|May 15, 2025
FDA Approves Retifanlimab, First Frontline Treatment for Advanced SCAC
Author(s)Sabrina Serani
Fact checked by: Jordyn Sava
With significant survival improvements seen, the FDA has granted approval to retifanlimab for the first-line treatment of advanced anal cancer.
- The FDA has approved retifanlimab-dlwr (Zynyz) for the treatment of advanced squamous cell carncinoma of the anal canal (SCAC) as a monotherapy and in combination with chemotherapy.
- This makes it the first and only approved first-line treatment in this intent-to-treat group.
- Retifanlimab led to significant improvements in progression-free survival (PFS) and overall survival (OS).
The PD-1 inhibitor retifanlimab is now the first and only FDA-approved first-line therapy as a single agent and in combination with chemotherapy for the treatment of advanced SCAC, achieving statistically significant improvements in PFS and OS in this patient population.1
"The FDA approval of [retifanlimab] marks a pivotal moment, bringing effective combination and monotherapy treatment options to patients with advanced anal cancer after decades of limited innovation," said Hervé Hoppenot, chief executive officer, Incyte, in a press release. "At Incyte, we focus our efforts where we can make the biggest impact for patients. I am proud of our scientists and development teams for their perseverance in delivering the first approved PD-1 inhibitor to US patients with SCAC.”
About POD1UM-303
The approval for this agent in combination with chemotherapy was supported by the phase 3 POD1UM-303/InterAACT2 trial (NCT04472429). Findings were presented at the
Additionally, patients who received retifanlimab achieved an overall response rate (ORR) of 56% (95% CI, 48%-64%), with a complete response (CR) rate of 22%, vs 44% (95% CI, 36%-52%) with a 14% CR rate among those who received placebo (P = .0129). The median duration of response (DOR) was 14.0 months (95% CI, 8.6-22.2) vs 7.2 months (95% CI, 5.6-9.3), respectively, and the respective disease control rates (DCRs) were 87% (95% CI, 81%-92%) vs 80% (95% CI, 73%-86%).
About POD1UM-202
The phase 2 POD1UM-202 (NCT03597295) study supports the approval of retifanlimab as a monotherapy.3Here, retifanlimab produced an ORR of 13.8% (95% CI, 7.6%-22.5%) with 1 CR and 12 partial responses. The DCR was 48.9% (95% CI, 38.%-59.5%), and the median DOR was 9.5 months (range, 5.6-not estimable).
The safety profile of retifanlimab was comparable with other PD-1 inhibitors. Serious adverse events (AEs) were reported in 40% of patients receiving retifanlimab. The most common serious AEs included nonurinary tract infection, perineal pain, abdominal pain, anemia, hemorrhage, diarrhea, pyrexia, urinary tract infection, musculoskeletal pain, and dyspnea.
REFERENCES:
1. Incyte announces FDA approval of Zynyz (retifanlimab-dlwr) making it the first and only approved first-line treatment for advanced anal cancer patients in the United States. News release. Incyte. May 15, 2025. Accessed May 15, 2025. https://tinyurl.com/53bf8ufw
2. Rao S, Samalin-Scalzi E, Evesque L, et al. POD1UM-303/InterAACT 2: phase 3 study of retifanlimab with carboplatin-paclitaxel (c-p) in patients (Pts) with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) not previously treated with systemic chemotherapy (Chemo). Presented at: 2024 ESMO Congress; September 13-17, 2024; Barcelona, Spain. Abstract LBA2.
3. Rao S, Anandappa G, Capdevila J, et al. A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). ESMO Open. 2022 Aug;7(4):100529. doi:10.1016/j.esmoop.2022.100529. Epub 2022 Jul 8.
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