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Amol Akhade: A New Era for Advanced Anal Cancer Treatment

Amol Akhade/hiranandanihospital.org

May 16, 2025, 17:35

Amol Akhade: A New Era for Advanced Anal Cancer Treatment

Amol Akhade, Senior Consultant Medical Oncologist and Hemato-Oncologist at Suyog Cancer Clinics and Reliance Hospitals, shared a post on LinkedIn:

“FDA Approves Zynyz (retifanlimab) – A New Era for Advanced Anal Cancer Treatment!

A major milestone in GI oncology and HPV-driven cancers.

On May 15, 2025, the FDA approved Zynyz (retifanlimab-dlwr), a PD-1 inhibitor, for:

First-line treatment of inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) – in combination with carboplatin + paclitaxel
Monotherapy in patients who progressed on or are intolerant to platinum-based chemotherapy

Mechanism of Action

Zynyz is a humanized anti–PD-1 monoclonal antibody.

It restores T-cell–mediated antitumor activity, particularly relevant in HPV-driven tumors like anal cancer.

Supporting Data: POD1UM-303 / InterAACT2 (Phase 3)

Patients: Previously untreated metastatic SCAC

Arms:

Zynyz + chemo (carboplatin + paclitaxel) Placebo + chemo Key Results

37% reduction in risk of progression or death (p = 0.0006)
Median PFS: 9.3 mo vs 7.4 mo
Median OS: +6.2 months (p = 0.0273) at interim
No new safety signals
Serious AEs (≥2%): sepsis (3.2%), PE (3.2%), diarrhea and vomiting (2.6%)

What Makes This Approval Historic?

First and only approved 1st-line immunotherapy for anal cancer
Marks a major success in a rare, HPV-associated, and underfunded malignancy
Expands the role of checkpoint inhibitors beyond melanoma, lung, cervical, and head and neck cancers

Patients with SCAC have long had limited treatment options and poor survival. The approval of Zynyz represents a practice-changing breakthrough and validates the immunogenic potential of HPV-driven tumors.

Let’s hope this paves the way for future trials in anal cancer and other rare GI tumors.”

Amol Akhade: A New Era for Advanced Anal Cancer Treatment