ImmunityBio converts from Immunomedics Message Board

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Biotech / Medical : ImmunityBio converts from Immunomedics

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To: End2War who wrote (1160)	9/8/2025 2:41:32 PM
From: End2War	5 Recommendations Recommended By bobbseytwins2001 CCS648 Huggenberg mannamal Stikkmann Read Replies (1) of 1216

Continuation Explain how this poster fits into the discussion we have been having, stocktwits.com Show thinking This poster fits perfectly into our discussion—in fact, it is the practical execution of the exact regulatory strategy we've been analyzing. If our previous conversation was about the theory and potential pathways for N-803, this poster for the ResQ201A trial is the detailed blueprint for making it a reality for lung cancer. Here’s exactly how it connects to our key discussion points: 1. It IS The Confirmatory Phase 3 Trial We discussed at length that if ImmunityBio seeks Accelerated Approval based on their promising Phase 2 data (from the first poster, QUILT-3.055), they are required by the FDA to conduct a confirmatory Phase 3 trial to verify the drug's benefit. This poster is the design for that exact confirmatory trial. A successful outcome from this large, randomized study is what would convert a potential Accelerated Approval into a full, traditional approval. 2. It Targets the "Salvage Therapy" Population Our most recent discussion focused on the strategic value of targeting patients where other treatments are failing. This trial does precisely that. The inclusion criteria specifically state it is for patients with "Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy." This is the high-unmet-need "salvage" population where N-803's novel mechanism could have the greatest impact. 3. The Endpoint is the Gold Standard We talked about the challenges of using surrogate endpoints (like tumor response) versus direct clinical benefits. Notice the Primary Endpoint for this Phase 3 trial is Overall Survival (OS). This is the ultimate, gold-standard endpoint in oncology. By designing the trial to prove that patients on the N-803 regimen live longer than those on standard chemotherapy, IBRX is aiming for the most definitive proof of clinical benefit, leaving no doubt for regulators. 4. It's the Path to "Label Expansion" We defined the process of getting N-803 approved for NSCLC as a "label expansion" from its current approval in bladder cancer. This Phase 3 trial is the vehicle for that expansion. The data generated from these 462 patients will form the core of the supplemental Biologics License Application (sBLA) that IBRX will submit to the FDA to add NSCLC to Anktiva's label. In short, the first poster you showed was the promising "teaser" from the Phase 2 study. This second poster is the "main event"—the large, expensive, and pivotal Phase 3 trial designed to provide the undeniable evidence needed for FDA approval in lung cancer. It is the tangible next step that connects all the strategic and regulatory concepts we have discussed.

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