Results from phase III POD1UM-304 trial of Zynyz ( retifanlimab ) + chemotherapy in NSCLC.- Incyte Inc.
Incyte announced results from the Phase III POD1UM-304 trial of retifanlimab (Zynyz ), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with platinum-based chemotherapy for the treatment of adults with previously untreated non-squamous and squamous metastatic non-small cell lung cancer (NSCLC) not harboring a driver mutation. These data were featured in a mini oral presentation at the European Society for Medical Oncology (ESMO) Asia Congress 2024, held in Singapore and virtually.
The POD1UM-304 trial results show a clinically meaningful and statistically significant improvement over chemotherapy alone. Patients in the retifanlimab and chemotherapy combination treatment group achieved a median overall survival (OS) of 18.1 months compared to 13.4 months in the placebo and chemotherapy combination group (Hazard Ratio [HR]: 0.75; 95% Confidence Interval [CI] (0.60, 0.93); P=0.0042).
“The positive POD1UM-304 trial results provide additional proof of retifanlimab’s safety and efficacy profile in solid tumors,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “We look forward to leveraging these results to advance our pipeline, particularly in hard-to-treat cancers like NSCLC, and to submitting a supplemental Biologic License Application for this indication to the U.S. Food and Drug Administration next year.”
The trial also met secondary endpoints, including: i. Patients who received retifanlimab in combination with chemotherapy had a 2-month improvement in median progression-free survival (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]). ii. Overall response rate (ORR) and duration of response (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 and no new safety issues were 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.
“Lung cancer is the leading cause of cancer deaths globally, with the high majority of cases being NSCLC,” said Shun Lu, M.D., Ph.D., Shanghai Chest Hospital. “I am encouraged by the observed safety and efficacy profile of retifanlimab when added to platinum-based chemotherapy in this patient population and believe the positive results from the POD1UM-304 trial support retifanlimab in combination with chemotherapy as an additional treatment option for previously untreated metastatic NSCLC.”
About POD1UM; The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-304 in non-small cell lung cancer (NSCLC) and POD1UM-303 in squamous cell anal carcinoma (SCAC), as well as other Phase 1 and II studies for patients with solid tumors, including registration-directed trials evaluating retifanlimab as a monotherapy for patients with Merkel cell carcinoma and microsatellite instability-high endometrial cancer.
About POD1UM-304; POD1UM-304 is a Phase III, global, multicenter, randomized, double-blind study evaluating platinum-based chemotherapy with retifanlimab or placebo in patients with first-line, metastatic squamous or non-squamous NSCLC.
During the study, patients were randomized to receive retifanlimab or placebo intravenously in combination with pemetrexed and carboplatin/cisplatin for non-squamous NSCLC, and with paclitaxel and carboplatin for squamous NSCLC. The primary endpoint is overall survival (OS), and secondary endpoints include progression-free survival (PFS), overall response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR). After verified progressive disease by BICR, patients assigned to the placebo and chemotherapy combination group had the option to cross over to open-label retifanlimab monotherapy.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
3 mins