Incyte's Retifanlimab: A Game Changer in Non-Small Cell Lung Cancer Treatment

Incyte Corporation, a leading biopharmaceutical company, has recently announced positive results from a Phase 3 trial evaluating the efficacy and safety of retifanlimab (Zynyz®) in combination with platinum-based chemotherapy for the treatment of patients with non-small cell lung cancer (NSCLC). These results have significant implications for the treatment of this aggressive disease and could potentially extend the lives of patients.

The trial, known as POD1UM-304, demonstrated a clinically meaningful and statistically significant improvement in overall survival (OS) for patients receiving retifanlimab in combination with chemotherapy compared to those receiving chemotherapy alone. Patients in the retifanlimab group achieved a median OS of 18.1 months, compared to 13.4 months in the placebo group (Hazard Ratio [HR]: 0.75; 95% Confidence Interval [CI] (0.60, 0.93); P=0.0042). This 4.7-month improvement in OS highlights the potential of retifanlimab in enhancing the efficacy of chemotherapy in NSCLC treatment.

In addition to the improvement in OS, the trial also met secondary endpoints, including progression-free survival (PFS), overall response rate (ORR), and duration of response (DOR). Patients who received retifanlimab in combination with chemotherapy had a 2-month improvement in median PFS compared to the placebo and chemotherapy combination group (7.7 vs 5.5 months; [HR: 0.64; 95% CI (0.52, 0.79); P<0.0001]). The ORR and DOR by Blinded Independent Central Review (BICR) each showed improvement in the retifanlimab and chemotherapy combination treatment group versus the placebo and chemotherapy combination group (ORR of 52% [95% CI (47, 57) vs. 39% (95% CI 32, 46), respectively; P=0.0012]; DOR of 12.7 months [95% CI (9.4, 15.2) vs. 6.1 months and [95% CI (4.2, 8.3), respectively]).

Retifanlimab was generally well-tolerated, with no new safety issues identified. The most common treatment-emergent adverse events (TEAEs), in >10% of patients in the retifanlimab and chemotherapy combination treatment group, were anemia (62.7%), decreased appetite (22.6%), and decreased neutrophil count (22.1%). Chemotherapy administration was not compromised by the addition of retifanlimab.



These results suggest that retifanlimab, when combined with chemotherapy, offers competitive benefits in NSCLC compared to other treatments. For instance, the median OS for pembrolizumab (Keytruda®) in combination with chemotherapy in the KEYNOTE-189 trial was 13.9 months, while atezolizumab (Tecentriq®) in combination with chemotherapy in the IMpower130 trial resulted in a median OS of 18.6 months. The PFS for pembrolizumab in the KEYNOTE-189 trial was 8.4 months, and for atezolizumab in the IMpower130 trial, it was 7.6 months. The ORR for pembrolizumab in the KEYNOTE-189 trial was 47.6%, and for atezolizumab in the IMpower130 trial, it was 46.8%. These comparisons suggest that retifanlimab, when combined with chemotherapy, may offer a more favorable OS, PFS, and ORR in NSCLC.



In conclusion, Incyte's recent Phase 3 trial results demonstrate the potential of retifanlimab (Zynyz®) in combination with platinum-based chemotherapy for the treatment of patients with previously untreated metastatic NSCLC. The significant improvement in overall survival, progression-free survival, overall response rate, and duration of response, along with a manageable safety profile, highlights the promise of this treatment combination. As Incyte continues to evaluate retifanlimab in other solid tumors, these results further support the potential of this drug in the broader oncology landscape. Investors should closely monitor Incyte's progress and consider the potential impact of these results on the company's valuation and future growth prospects.