June 28, 2024 - 🧬 [nGram] Today’s Oncology Scoop: FDA Approvals, New Data, and Clinical Trial Updates

  1. Shorla Oncology announces FDA approval for Tepylute, a novel formulation to treat breast and ovarian cancer
    • Shorla Oncology received FDA approval for Tepylute, a ready-to-dilute injectable formulation for breast and ovarian cancer.
    • Tepylute simplifies preparation and ensures dosing accuracy, addressing the complexities of the current lyophilized powder formulation.
    • This is Shorla's third FDA-approved drug and the first in-house developed NDA.
    • Tepylute is a liquid form of thiotepa, eliminating the need for reconstitution and reducing preparation errors.
    • The American Cancer Society estimates over 300,000 breast cancer and 19,680 ovarian cancer diagnoses in the U.S. in 2024.
    • Shorla is also awaiting FDA action on SH-201, an oral liquid treatment for leukemia, expected by November 30, 2024.
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  2. IASO Bio's GPRC5D CAR-T product RD118 receives IND approval from NMPA
    • IASO Bio's RD118, a GPRC5D-targeting CAR-T therapy, received IND approval from the NMPA for treating relapsed/refractory multiple myeloma (RRMM).
    • RD118 is an autologous T-cell immunotherapy targeting GPRC5D, which is highly expressed on multiple myeloma cells.
    • The therapy has shown excellent in vitro cytotoxic activity and in vivo tumor suppression ability.
    • An investigator-initiated clinical trial (IIT) is ongoing to evaluate the safety and efficacy of RD118 in patients with RRMM or plasma cell leukemia.
    • The trial includes patients who have received at least three lines of therapy, including proteasome inhibitors and immunomodulators, and those who have had prior BCMA CAR-T therapy.
    • The dose-escalation phase of the trial has completed subject enrollment and infusion, showing good safety and efficacy profiles.
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  3. Oncolytics Biotech announces productive FDA type C meeting on its metastatic breast cancer program
    • Oncolytics Biotech received positive feedback from the FDA on its planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC).
    • The FDA supports progression-free survival as the primary endpoint and overall survival as a key secondary endpoint for the study.
    • The trial will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy.
    • Oncolytics is on track to report overall survival results from the BRACELET-1 trial in HR+/HER2- mBC in the second half of 2024.
    • The company aims to initiate the registration-enabling trial as a major corporate objective.
    • Pelareorep has shown promising results in previous studies, including BRACELET-1, IND-213, and AWARE-1, highlighting its immune-mediated mechanism of action.
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  4. New efficacy data for non-clear cell renal cell carcinoma from KEYNOTE-B61 added to LENVIMA US label
    • Eisai announced a label update for LENVIMA in the US to include clinical efficacy data for the first-line treatment of advanced non-clear cell renal cell carcinoma (nccRCC).
    • The update is based on data from KEYNOTE-B61, a Phase 2, single-arm trial evaluating KEYTRUDA plus LENVIMA for the first-line treatment of adult patients with advanced nccRCC.
    • KEYNOTE-B61 enrolled 160 patients and showed an objective response rate (ORR) of 51%, with a complete response rate of 8% and a partial response rate of 42%.
    • The median duration of response (DOR) was 19.5 months, with no new safety signals observed.
    • KEYTRUDA plus LENVIMA is now the first and only combination with data in both clear cell and non-clear cell advanced RCC in the FDA-approved label.
    • The approved indication for KEYTRUDA plus LENVIMA for the first-line treatment of adult patients with advanced RCC remains unchanged.
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  5. Sirnaomics completes phase I study of STP707 for pancreatic cancer
    • Sirnaomics completed a Phase I clinical study of STP707 for pancreatic cancer patients.
    • The dose escalation study was conducted in 11 oncology clinics in the U.S. with six cohorts and 50 patients.
    • The study aimed to evaluate the safety, tolerability, and anti-tumor activity of STP707 through intravenous infusion.
    • 11 pancreatic cancer patients were enrolled, with an average of three prior lines of therapy.
    • No treatment-related adverse events were reported, except for one Grade 2 infusion reaction.
    • The study showed a strong safety profile and stable disease activity, warranting further research.
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  6. 50% ORR: impressive clinical trial data for irpagratinib combined with atezolizumab in advanced hepatocellular carcinoma stuns ESMO-GI congress
    • Abbisko Therapeutics presented new phase II clinical data at the 2024 ESMO-GI Congress.
    • The combination of irpagratinib (220 mg BID) and atezolizumab showed a 50% objective response rate (ORR) in FGF19+ HCC patients.
    • Strong efficacy and good safety were observed, even in patients previously treated with immune checkpoint inhibitors.
    • Abbisko plans to explore dual/triple combinations with irpagratinib in earlier lines of therapy for HCC.
    • Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, with FGF19-FGFR4 signaling dysregulation accounting for about 30% of cases.
    • Further research and innovation are planned to better address HCC and bring hope to patients.
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  7. AbbVie receives positive CHMP opinion for epcoritamab for relapsed/refractory follicular lymphoma
    • Epcoritamab (TEPKINLY) is set to become the first bispecific antibody conditionally approved as a monotherapy in the EU for relapsed/refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL).
    • The positive CHMP opinion is based on results from the Phase 1/2 EPCORE NHL-1 study, which included 128 patients with relapsed/refractory FL.
    • The study showed overall and complete response data, with a safety profile similar to previous reports of epcoritamab monotherapy.
    • An additional cohort of 86 patients evaluated a 3-step-up dosing schedule to reduce cytokine release syndrome (CRS), with no grade 3 or higher CRS events reported.
    • Epcoritamab is being co-developed by AbbVie and Genmab, with AbbVie responsible for global commercialization.
    • The European Commission decision on this indication for epcoritamab is anticipated later this year, with further international regulatory approvals being pursued.
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  8. Epcoritamab receives positive CHMP opinion for the treatment of adults with relapsed/refractory follicular lymphoma
    • The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorization for epcoritamab as a monotherapy for relapsed/refractory follicular lymphoma (FL).
    • The recommendation is based on data from the Phase 1/2 EPCORE NHL-1 clinical trial, which included 128 patients with R/R FL.
    • The trial showed overall and complete response rates, with common adverse reactions including CRS, injection site reactions, and neutropenia.
    • An additional cohort of 86 patients evaluated an optimized step-up dosing (SUD) schedule to reduce the incidence and severity of cytokine release syndrome (CRS).
    • The final decision from the European Commission on this indication for epcoritamab is expected later this year.
    • Genmab and AbbVie are co-developing epcoritamab and will share commercial responsibilities in the U.S. and Japan, with AbbVie handling further global commercialization.
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  9. Cancer Therapy Evaluation Program announces availability of botensilimab for clinical studies
    • The Cancer Therapy Evaluation Program (CTEP) is now accepting Letters of Intent (LOIs) for clinical studies using botensilimab.
    • Botensilimab is a human Fc enhanced next-generation anti-CTLA-4 antibody developed by Agenus Inc. in collaboration with CTEP.
    • CTEP will also consider supplying botensilimab for nonclinical studies.
    • Agenus is committed to supporting both clinical and nonclinical research by providing botensilimab and its mouse surrogate.
    • Botensilimab has shown clinical responses in phase 1 and phase 2 trials across nine metastatic, late-line cancers.
    • For more information on botensilimab trials, visit clinicaltrials.gov with identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.
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  10. Bicara Therapeutics reports updated interim phase 1/1b data of ficerafusp alfa in 1L HPV-negative recurrent/metastatic head and neck squamous cell carcinoma
    • Bicara Therapeutics presented updated interim data from its ongoing Phase 1/1b dose expansion study of ficerafusp alfa at the 3rd Hawaii Global Summit on Thoracic Malignancies.
    • Ficerafusp alfa, a bifunctional antibody, showed a 64% overall response rate (ORR) and 18% complete response (CR) rate in combination with pembrolizumab in HPV-negative R/M HNSCC patients.
    • The median progression-free survival (mPFS) was 9.8 months, with a favorable tolerability profile.
    • The study included 39 evaluable frontline R/M HNSCC patients, with 28 being HPV-negative.
    • Bicara plans to initiate a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in frontline R/M HNSCC excluding HPV-positive patients.
    • Next steps include exploring the potential of ficerafusp alfa in other HNSCC populations and squamous cell tumor types.
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