Oncology

Bristol Myers Squibb Receives Positive CHMP Opinion for Repotrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer and Advanced NTRK-Positive Solid Tumors

11/21/2024

Recommendation based on data from registrational TRIDENT-1 and CARE trials, which demonstrated robust responses and durable activity with repotrectinib in these patient populations If approved, repotrectinib has the potential to be a best-in-class treatment for patients with advanced ROS1-positive non-small cell lung cancer in the European Union Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers…

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Nektar and Collaborators Present Late-breaking Results from Phase 2 Study of NKTR-255 for the Treatment of Radiation Induced Lymphopenia in Locally Advanced Non-Small Cell Lung Cancer Patients at Society for Immunotherapy of Cancer (SITC) Annual Meeting

11/14/2024

NKTR-255 administered post completion of concurrent chemoradiation and in combination with durvalumab demonstrated statistically significant lymphocyte recovery compared to historical controls at week 8 – – Pharmacodynamic data show NKTR-255 increased NK cell proliferation and markers of NK cell activation  – Excerpt from the Press Release: SAN FRANCISCO, Nov. 7, 2024 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR)…

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Strong Evidence of AU-007’s Anti-Tumor Activity in Advanced Solid Tumor Cancers Presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting

11/13/2024

Excerpt from the Press Release: LARKSPUR, Calif.–(BUSINESS WIRE)–Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of potentially best-in-class IL-2 therapeutics, today shared positive results from its Phase 1/2 dose escalation and cohort expansion study of AU-007. The data will be presented in a poster session at the Society for Immunotherapy of…

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Verastem Oncology Completes Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

11/12/2024

Recurrent low-grade serous ovarian cancer is a rare cancer with no FDA-approved treatments Company seeking accelerated approval and priority review of its NDA submission in patients with KRAS mutant low-grade serous ovarian cancer; FDA filing decision expected before the end of 2024 with potential for FDA approval decision by mid-2025 Excerpt from the Press Release:…

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ESSA Pharma Announces Termination of Phase 2 Study Evaluating Masofaniten Combined with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

11/08/2024

Efficacy signals observed will not achieve ESSA’s target product profile in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens A futility analysis conducted as part of a protocol-specified interim review of the safety, PK and efficacy data showed the single-agent enzalutamide control arm performing better than historical controls and similar to the combination…

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Verastem Oncology Presents Positive Updated RAMP 201 Data for Avutometinib and Defactinib Combination in Recurrent Low-Grade Serous Ovarian Cancer at the International Gynecologic Cancer Society (IGCS) 2024 Annual Meeting

10/24/2024

Robust overall response rates observed (31% overall, 44% in KRAS mutant, 17% in KRAS wild-type) in patients whose cancer had progressed despite prior treatment with chemotherapy and/or MEK inhibitors and/or bevacizumab Patients on avutometinib and defactinib achieved a median progression free survival of more than one year (12.9 months); 22 months in KRAS mutant population…

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New Data Presented at ASTRO 2024 Show that Veracyte’s Decipher Prostate Test Predicts Aggressive Prostate Cancer in African American Men

10/11/2024

Findings are from the prospective, multicenter VANDAAM trial Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, announced that new data from the multicenter, prospective VANDAAM trial show that the Decipher Prostate Genomic Classifier accurately predicts aggressive prostate cancer among African American men with early-stage disease.…

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Jaguar Health Reports Statistically Significant Improvement in Breast Cancer Patients in its Phase 3 OnTarget Trial for its Cancer Supportive Care Drug Crofelemer

10/10/2024

Adult patients with breast cancer are a prespecified subgroup of the recently conducted OnTarget trial evaluating crofelemer for prophylaxis of cancer therapy-related diarrhea OnTarget results in breast cancer patients have been submitted to a relevant oncology conference Excerpt from the Press Release: SAN FRANCISCO, CA / ACCESSWIRE / October 1, 2024 / Jaguar Health, Inc.…

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Immuneering Announces Positive Initial Phase 2a Data Including Complete and Partial Responses with IMM-1-104 in Combination with Chemotherapy in First-Line Pancreatic Cancer Patients

09/20/2024

– In Phase 2a arm investigating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel, complete or partial responses have been observed in the first two patients (2/5) to date, for an initial response rate of 40% and an initial disease control rate of 80%, with all five patients continuing on treatment – – Initial data are at…

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Tempo Therapeutics Announces First Patient Dosed in Clinical Trial of TT101 For Tissue Repair in Skin Cancer Surgery

09/12/2024

First Application of MAP technology in humans to drive regenerative biologic response and spare scarring Excerpt from the Press Release: SAN DIEGO, Sept. 5, 2024 /PRNewswire/ — Tempo Therapeutics, Inc. (“Tempo”), a leading innovator in tissue engineering and regenerative medicine, today announced the dosing of the first patients in a clinical trial of TT101 (the…

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