FDA approves Merck’s Keytruda plus chemotherapy for first-line treatment of advanced mesothelioma
- The FDA has approved Keytruda in combination with pemetrexed and platinum chemotherapy for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
- Approval is based on the Phase 2/3 IND.227/KEYNOTE-483 trial, which showed a 21% reduction in the risk of death compared to chemotherapy alone.
- Keytruda plus chemotherapy also improved progression-free survival (PFS) and overall response rate (ORR) compared to chemotherapy alone.
- The trial enrolled 440 patients and demonstrated significant improvements in overall survival (OS), PFS, and ORR for the Keytruda combination.
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Transcenta updates efficacy data from first-line triple combo trial of osemitamab for G/GEJ cancer at ESMO 2024
- Updated results show a confirmed ORR of 68% and median PFS of 14.2 months in patients with high or medium CLDN18.2 expression.
- The trial involved Osemitamab (TST001) plus Nivolumab and CAPOX as first-line treatment for advanced G/GEJ cancer.
- The data supports the synergistic mechanism between CLDN18.2 targeting agents and checkpoint inhibitors.
- The 12-month survival rate for the overall population in this cohort was 73.8%.
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Abbisko announces updated clinical data of irpagratinib in HCC
- Abbisko Therapeutics received the ESMO 2024 Best Poster Award for their presentation on irpagratinib in advanced hepatocellular carcinoma (aHCC).
- The Phase 1 study showed a tolerable safety profile and promising anti-tumor activity, with an ORR of 44.8% and DCR of 79.3% in pretreated aHCC patients.
- 122 patients were enrolled, with 74 in the BID cohort. The most common treatment-related adverse effects included ALT elevation, diarrhea, and AST elevation.
- Irpagratinib demonstrated a 44.8% ORR, 7.4 months mDoR, and 5.5 months mPFS in heavily pre-treated HCC patients, supporting further late-stage development.
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Xspray Pharma announces positive FDA meeting and plans for Dasynoc NDA resubmission
- Xspray Pharma plans to resubmit its NDA for Dasynoc in Q4 2024, following a productive meeting with the FDA.
- FDA recommended adjustments to Dasynoc's tablet strengths to reduce medication errors, requiring new batches to be produced.
- The company has initiated production of these new batches and will provide further clarification on the manufacturing process.
- A new PDUFA date will be assigned upon resubmission, with a final decision expected within two to six months.
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InnoCare announces approval of clinical trial of BCL2 inhibitor ICP-248 for acute myeloid leukemia in China
- InnoCare Pharma received IND approval to conduct a clinical trial of BCL2 inhibitor ICP-248 in combination with azacitidine for AML in China.
- AML is a malignant hematological disease, accounting for about 80% of acute leukemia in adults and 15-20% in pediatric cases.
- ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor that restores programmed cell death mechanisms.
- InnoCare aims to accelerate clinical development to benefit patients with hematological malignancies.
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GOZILA study shows liquid biopsy-guided treatment doubles survival in advanced cancer
- The GOZILA study, published in Nature Medicine, involved 4,037 patients with advanced cancer.
- 24% of participants received targeted treatment based on Guardant360 CDx liquid biopsy results.
- Patients receiving targeted therapy had a median survival of 18.6 months, compared to 9.9 months for those who did not.
- The study demonstrates the potential of liquid biopsy to significantly extend patient survival across various cancers.
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Azitra receives fast track designation for ATR-04 for skin rash from EGFR inhibitors
- Azitra's ATR-04 has been granted Fast Track Designation by the FDA for treating moderate to severe EGFR inhibitor-associated dermal toxicity.
- The Fast Track program aims to expedite the development and review of therapies addressing significant unmet medical needs.
- ATR-04 is a live biotherapeutic product containing a genetically engineered strain of Staphylococcus epidermidis.
- Azitra plans to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04 by the end of 2024.
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Oncolytics Biotech reports favorable results for BRACELET-1 breast cancer study
- BRACELET-1 Phase 2 study shows promising results for pelareorep in HR+/HER2- advanced or metastatic breast cancer.
- Median overall survival (OS) not reached in pelareorep + paclitaxel arm; estimated median OS at least 32 months vs. 18 months for control.
- Two-year survival rate: 64% for pelareorep + paclitaxel vs. 33% for paclitaxel monotherapy.
- Oncolytics Biotech plans to secure funding for a registration-enabling study based on these results.
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Brenus Pharma raises $25 million to accelerate clinical trials of its precision cancer vaccines
- Brenus Pharma completed a $25 million Series A financing round led by Angelor, with participation from UI Investissement, Crédit Agricole, Noshaq, and Investsud.
- Funds will be used to fully fund the STC-1010 cancer vaccine’s first-in-human proof-of-concept trial for metastatic colorectal cancer patients.
- STC-1010 is based on the STC 'Stimulated-Tumor-(ghost)-Cells' technology platform, offering a new type of precision treatment.
- The phase I/IIA 'BreAK-CRC' study for STC-1010 is under review by European regulatory authorities and will evaluate safety, efficacy, and progression-free survival.
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