Exelixis provides regulatory update on cabozantinib for advanced neuroendocrine tumors
- The FDA will discuss the sNDA for cabozantinib in advanced pNET and epNET at an ODAC meeting in March 2025.
- The sNDA is based on the phase 3 CABINET trial, which showed significant improvement in progression-free survival.
- The FDA granted orphan drug designation to cabozantinib for pNET, with a target action date of April 3, 2025.
- The CABINET trial was a multicenter, double-blinded, placebo-controlled study with 298 patients.
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Anocca submits clinical trial application for VIDAR-1 in advanced pancreatic cancer
- Anocca has submitted a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for the VIDAR-1 Phase I/II trial.
- The trial will focus on ANOC-001, targeting mutant KRAS G12V in advanced pancreatic cancer.
- VIDAR-1 is a multi-asset umbrella trial designed to investigate up to 20 patients per product.
- Subject to approval, the trial is expected to start in Q2, 2025.
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Roche to acquire Poseida Therapeutics for $1.5 billion
- Roche will acquire Poseida Therapeutics for $9.00 per share, totaling approximately $1.0 billion, with potential additional payments up to $1.5 billion.
- The acquisition includes Poseida's cell therapy candidates and platform technologies, enhancing Roche's capabilities in oncology, immunology, and neurology.
- Poseida's lead program, P-BCMA-ALLO1, targets multiple myeloma and has received FDA designations.
- The transaction is expected to close in Q1 2025, subject to customary conditions.
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Delta-Fly Pharma updates on phase III trial of DFP-14323
- DFP-14323 is in a Phase III trial for EGFR mutation-positive NSCLC.
- The trial compares DFP-14323 with Afatinib to Afatinib alone.
- Conducted at 30 hospitals in Japan, focusing on progression-free survival.
- Plans for development collaboration with a global pharmaceutical company.
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Roche reports update on phase III SKYSCRAPER-01 study results
- Roche's phase III SKYSCRAPER-01 study evaluated tiragolumab with Tecentriq in PD-L1-high NSCLC patients.
- The study involved 534 patients, randomized to receive either the combination or Tecentriq alone.
- Primary endpoint of overall survival was not met; safety profile remained consistent with no new signals.
- Detailed data to be presented at a medical meeting in 2025, with further studies anticipated next year.
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Shuttle Pharma expands patient enrollment for phase 2 clinical trial of ropidoxuridine for glioblastoma
- Shuttle Pharmaceuticals has begun patient enrollment and dosing at UVA Cancer Center for its Phase 2 trial of Ropidoxuridine.
- The trial involves 40 patients with glioblastoma, randomized into two dose groups to determine the optimal dose.
- Ropidoxuridine is a radiation sensitizer aimed at improving outcomes for patients with aggressive brain tumors.
- The trial is being conducted at six cancer centers, including Georgetown University and Miami Cancer Institute.
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Study details how cancer cells fend off starvation and death from chemotherapy
- Research reveals how cancer cells evade chemotherapy by altering their metabolism in low-glucose environments.
- Three antimetabolic drugs studied: raltitrexed, PALA, and brequinar, which disrupt pyrimidine synthesis.
- Low-glucose environments slow uridine nucleotide consumption, reducing chemotherapy effectiveness.
- Future therapies may target cancer cell pathways to enhance chemotherapy response in low-glucose conditions.
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New data from long-term follow-up study of the OLYMPUS trial
- UroGen Pharma released long-term follow-up data for JELMYTO, showing a median duration of response of 47.8 months in patients with low-grade upper tract urothelial cancer (LG-UTUC).
- The study involved 41 patients from the OLYMPUS trial, with 20 entering the long-term follow-up phase.
- JELMYTO is FDA-approved for treating LG-UTUC and offers a kidney-sparing treatment option.
- Further research is ongoing with the JELMYTO uTRACT Registry to collect real-world data.
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European Commission approves BeiGene’s Tevimbra for first-line treatment of advanced esophageal and gastric cancers
- The European Commission has approved Tevimbra (tislelizumab) in combination with chemotherapy for first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
- Approval is based on results from the RATIONALE-305 and 306 trials, showing significant overall survival benefits in patients with PD-L1 expressing tumors.
- In ESCC, the median overall survival was 17.2 months with Tevimbra versus 10.6 months with placebo, while in G/GEJ cancer, it was 15.0 months versus 12.9 months.
- Tevimbra is already approved in the EU for other indications, and BeiGene plans to change its name to BeOne Medicines.
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Kelun-Biotech's TROP2 ADC sacituzumab tirumotecan approved for marketing by NMPA of China for 2L+ advanced or metastatic TNBC
- Kelun-Biotech's sacituzumab tirumotecan (sac-TMT) received marketing authorization from China's NMPA for advanced or metastatic triple-negative breast cancer (TNBC).
- Approval is based on positive results from the phase 3 OptiTROP-Breast01 study, showing significant improvement in progression-free and overall survival.
- Sac-TMT is the first domestically developed TROP2 ADC approved in China, marking a significant milestone for Kelun-Biotech.
- Future plans include exploring sac-TMT's clinical value in other indications and maximizing its market potential.
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Aulos Bioscience doses first patient in phase 2 cohort for NSCLC treatment
- Aulos Bioscience has dosed the first patient in a Phase 2 cohort evaluating AU-007 and avelumab for PD-L1+ non-small cell lung cancer (NSCLC).
- The trial is a collaboration with Ares Trading S.A., a subsidiary of Merck KGaA, and part of Aulos' ongoing Phase 1/2 clinical trial.
- AU-007 is a human IgG1 monoclonal antibody designed using AI, showing promising anti-tumor activity in preclinical studies.
- Preliminary data from this cohort is expected in the first half of 2025.
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Lin BioScience receives U.S. FDA fast track designation for LBS-007
- LBS-007, a treatment for acute myeloid leukemia, has received Fast Track Designation from the U.S. FDA.
- The designation aims to expedite the development and review of drugs addressing serious conditions with unmet medical needs.
- A Phase 1/2 trial is ongoing in the US, Australia, and Taiwan for patients with relapsed or resistant acute leukemias.
- LBS-007 has also been granted orphan drug designations for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA.
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Sellas identifies ASXL1 mutations as predictor for SLS009 response in solid cancers
- Preclinical studies show SLS009 is highly effective in 67% of ASXL1 mutated solid cancers.
- ASXL1 mutations identified in colorectal cancer (CRC MSI-H) and non-small cell lung cancer (NSCLC).
- SLS009 demonstrated high efficacy in ASXL1 mutated cell lines, outperforming standard controls.
- Sellas plans targeted clinical trials for SLS009 in selected solid cancers.
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Dr. Reddy's launches Toripalimab in India for nasopharyngeal carcinoma
- Dr. Reddy's Laboratories has launched Toripalimab in India, marking it as the first immuno-oncology drug approved for nasopharyngeal carcinoma (NPC).
- Toripalimab is approved by major regulatory bodies like USFDA, EMA, and MHRA for treating recurrent or metastatic NPC.
- The drug is launched under a license agreement with Shanghai Junshi Biosciences, granting Dr. Reddy's exclusive rights in 21 countries.
- Toripalimab is indicated for use with chemotherapy, showing a 48% reduction in risk of progression or death.
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HUTCHMED announces continued inclusion of Orpathys in China's national reimbursement drug list
- Orpathys (savolitinib) will remain on China's National Reimbursement Drug List (NRDL) under the same terms as the current agreement.
- The drug is a selective MET tyrosine kinase inhibitor approved for non-small cell lung cancer with MET exon 14 skipping alterations.
- Orpathys was first included in the NRDL in March 2023, and the list is updated annually with renewals every two years.
- The inclusion aims to improve drug affordability, with varying copayment requirements based on insurance schemes.
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