Summary of Immunome's Conference Call on AL102 Phase 3 Results Company and Industry Overview - **Company**: Immunome - **Industry**: Oncology, specifically focusing on desmoid tumors Key Points and Arguments 1. **Positive Phase 3 Results**: The top-line results from the AL102 Ringside phase 3 clinical trial for desmoid tumors were reported as positive, indicating the potential for AL102 to be a best-in-class treatment [4][5][6] 2. **Primary and Secondary Endpoints**: The trial met all primary and secondary endpoints, including: - Progression-Free Survival (PFS) hazard ratio of 0.16, indicating a significant reduction in disease progression risk compared to placebo [5][10] - Confirmed Objective Response Rate (ORR) of 56%, the highest reported in randomized trials for desmoid tumors [5][11] - Median tumor volume reduction of 83%, with placebo showing an 11% increase [5][12] 3. **Safety Profile**: AL102 was generally well tolerated, with a manageable safety profile consistent with the gamma secretase inhibitor (GSI) class. Common adverse events included diarrhea, fatigue, and rash, primarily grade one or two [5][13] 4. **Ovarian Toxicity**: Notably, 55.6% of women of childbearing potential experienced ovarian toxicity, which is a known side effect of GSIs. This rate is lower than the up to 75% reported in the GSI class [13][14] 5. **Regulatory Plans**: Immunome plans to meet with the FDA in early 2026 to review the trial results and aims to submit a New Drug Application (NDA) in the second quarter of 2026 [6][14] 6. **Commercial Strategy**: The company is focused on a three-pillar strategy (start, support, scale) to drive adoption of AL102 upon approval, targeting approximately 11,000 actively managed desmoid tumor patients in the U.S. [25][26] 7. **Market Dynamics**: There are about 85 specialty sarcoma centers in the U.S. that treat desmoid tumors, which will facilitate efficient engagement and rapid uptake of AL102 [26][27] 8. **Future Studies**: Additional studies are planned to explore AL102's efficacy in treating other tumors and to better understand its impact on patients with functional impairments [14][61] Other Important Insights 1. **Patient Impact**: Desmoid tumors significantly affect the quality of life, often leading to debilitating pain and loss of function, particularly in younger patients [17][18] 2. **Treatment Landscape Evolution**: The treatment approach for desmoid tumors has shifted from surgery to active surveillance and systemic therapy, with GSIs emerging as a viable option [19][20] 3. **Clinical Experience**: The call featured insights from Dr. Mrinal Gounder, an expert in desmoid tumors, who emphasized the potential of AL102 to become a standard of care based on its clinical profile [20][23] 4. **Payer Coverage**: The expectation is for over 90% payer coverage at launch, supported by the familiarity of key opinion leaders (KOLs) with AL102 [27][28] 5. **Pricing Strategy**: While specific pricing details were not disclosed, the company plans to engage with payers and doctors to determine an appropriate price for AL102 [72] This summary encapsulates the critical aspects of Immunome's conference call regarding the promising results of AL102 for desmoid tumors, highlighting its potential impact on patient care and the company's strategic plans moving forward.