June 21, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Allogene's Phase 2 Trial, Oncolytics' New Study, Tempest's Survival Data

1. Allogene Therapeutics initiates pivotal phase 2 trial investigating cemacabtagene ansegedleucel (cema-cel) for large B-cell lymphoma

   • Allogene Therapeutics has launched the pivotal Phase 2 ALPHA3 trial for cemacabtagene ansegedleucel (cema-cel) as part of first-line treatment for large B-cell lymphoma (LBCL).
   • The trial will use Foresight Diagnostics' CLARITY™ test to identify patients with minimal residual disease (MRD) likely to relapse after standard first-line treatment.
   • Cema-cel will be administered as a one-time infusion immediately upon detection of MRD after six cycles of R-CHOP or other standard chemoimmunotherapy regimens.
   • The study aims to enroll approximately 240 patients and demonstrate a meaningful improvement in event-free survival (EFS) compared to the current standard of care.
   • Interim EFS analysis is expected in the first half of 2026, with a primary EFS analysis in the second half of 2026, and a potential biologics license application (BLA) submission in 2027.
   • The trial will be conducted across various cancer treatment centers, including community cancer centers where most first-line patients are managed.
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2. Oncolytics Biotech doses first patient in study of pelareorep/FOLFIRINOX combination therapy in pancreatic cancer

   • Oncolytics Biotech has dosed the first patient in the GOBLET study cohort evaluating pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients.
   • The study is supported by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN).
   • The co-primary endpoints of the cohort are objective response rate (ORR) and safety.
   • The study will be conducted in collaboration with AIO-Studien-gGmbH, a clinical trial group within the German Cancer Society.
   • If the combination of pelareorep and mFOLFIRINOX demonstrates promising efficacy, it could lead to a second pancreatic cancer registration program for Oncolytics.
   • The GOBLET study is a Phase 1/2 multiple indication study evaluating pelareorep-based combinations in gastrointestinal cancers.
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3. Tempest unveils new survival data for amezalpat (TPST-1120) in randomized first-line HCC study demonstrating a six-month improvement over control arm

   • Amezalpat arm shows a median overall survival (OS) of 21 months vs. 15 months in the control arm.
   • 50% of patients on the amezalpat arm remain in survival follow-up.
   • Hazard ratio (HR) for OS is 0.65, stable since the primary analysis.
   • Early and persistent separation of survival curves observed.
   • The study is part of Roche’s Morpheus program, evaluating amezalpat in combination with atezolizumab and bevacizumab.
   • Tempest retains all product rights to amezalpat.
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4. Medigene AG announces lead selection for MDG2021, expanding TCR-T KRAS library targeting solid tumors

   • Medigene AG has selected its lead candidate for MDG2021, a TCR-T therapy targeting KRAS G12D with HLA-A*11.
   • The therapy is developed in combination with Medigene’s PD1-41BB costimulatory switch protein (CSP) technology.
   • The selected TCR meets criteria for high specificity, sensitivity, and safety, showing no recognition of healthy cells and tissues.
   • MDG2021 will advance into the pre-clinical stage, with initial data to be presented at scientific conferences in the second half of 2024.
   • The new 3S TCR is designed to enhance TCR-T cell proliferation, persistence, and cytotoxic function while mitigating immunosuppressive effects.
   • MDG2021 is part of Medigene’s broader MDG20xx program, which explores other KRAS neoantigen mutations and HLAs.
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5. ImmunityBio announces insurance coverage of Anktiva across multiple states

   • ImmunityBio has begun treating patients with Anktiva, an immunotherapy for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.
   • Anktiva was approved by the FDA on April 22, 2024, for BCG-unresponsive NMIBC CIS with or without papillary tumors.
   • The therapy combines Anktiva, an IL-15 agonist, with BCG to activate NK and killer T-cells, achieving prolonged complete responses.
   • The first commercial doses have been administered to patients across the U.S., including those treated by community urologists.
   • Anktiva received Breakthrough Therapy Designation and FDA approval based on a single-arm, multicenter trial with a 62% complete response rate.
   • ImmunityBio has sufficient drug substance for 170,000 doses and offers support through the ImmunityBio CARE program.
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6. InnoCare announces acceptance of biologics license application for tafasitamab in combination with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma in China

   • China National Medical Products Administration (NMPA) has accepted and granted priority review to the BLA for tafasitamab in combination with lenalidomide.
   • The treatment targets adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
   • Tafasitamab is a humanized Fc-modified cytolytic CD19-targeting immunotherapy.
   • The combination therapy is already approved in Hong Kong and under early access programs in specific regions of China.
   • Tafasitamab has received accelerated approval by the U.S. FDA and conditional approval by the EMA for similar indications.
   • DLBCL is the most common type of non-Hodgkin lymphoma, accounting for 45.8% of all NHLs in China.
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7. European Medicines Agency validates Bristol Myers Squibb’s application for subcutaneous nivolumab

   • The European Medicines Agency (EMA) has validated Bristol Myers Squibb's application for a new subcutaneous route of administration for Opdivo (nivolumab).
   • The application includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) for multiple previously approved adult solid tumor indications.
   • The validation is based on results from the Phase 3 CheckMate -67T study, which demonstrated noninferiority of subcutaneous nivolumab compared to intravenous (IV) Opdivo.
   • The study's primary endpoints were time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady state (Cminss).
   • The safety profile of subcutaneous nivolumab was consistent with the IV formulation, and the pharmacokinetics, efficacy, and safety results were presented at the 2024 ASCO Genitourinary Cancers Symposium.
   • Next steps include the EMA's centralized review procedure to potentially introduce the subcutaneous option of Opdivo.
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8. Kiromic BioPharma provides updates on its Deltacel-01 clinical trial

   • Kiromic BioPharma reports follow-up results from the second, third, and fourth patients in its Deltacel-01 Phase 1 clinical trial.
   • The trial evaluates Deltacel (KB-GDT-01), an allogeneic, off-the-shelf Gamma Delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC).
   • The third and fourth patients showed stable disease at their follow-up visits, with no dose-limiting toxicities.
   • The second patient, initially showing stable disease and a complete response in brain metastasis, started a new course of treatment due to a new sub-cutaneous metastasis.
   • Kiromic BioPharma has submitted a request for Fast Track designation for Deltacel to the FDA to expedite its development and review.
   • The fifth patient completed their 30-day safety visit with no toxicities, and the sixth patient is expected to be enrolled in July.
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