Breast Cancer Network Australia’s Post

"A next-generation form of chemotherapy from AstraZeneca and Daiichi Sankyo has won Food and Drug Administration authorization for a form of breast cancer, the first U.S. approval for a drug for which the companies have high expectations. In its pivotal study in breast cancer, called TROPION-Breast01, Datroway significantly improved how long patients lived before their cancer started progressing again versus standard chemotherapy" https://lnkd.in/eqpDTWFW

Lisata Therapeutics Inc (NASDAQ:LSTA) announced that it has completed patient enrollment in all three cohorts of its Phase 1b/2a CENDIFOX trial evaluating the safety and efficacy of Lisata’s investigational drug certepetide in combination with FOLFIRINOX-based therapies for pancreatic, colon and appendiceal cancers. Certepetide is a cyclic peptide designed to enhance the delivery of anti-cancer drugs by activating a unique pathway that helps them target and penetrate solid tumors more effectively. The CENDIFOX trial has enrolled 66 patients, including 35 with resectable or borderline resectable pancreatic cancer, 18 with high-grade colon and appendiceal cancer... http://ow.ly/ZS4x105RcFx

Lisata Therapeutics Inc (NASDAQ:LSTA) announced that it has completed patient enrollment in all three cohorts of its Phase 1b/2a CENDIFOX trial evaluating the safety and efficacy of Lisata’s investigational drug certepetide in combination with FOLFIRINOX-based therapies for pancreatic, colon and appendiceal cancers. Certepetide is a cyclic peptide designed to enhance the delivery of anti-cancer drugs by activating a unique pathway that helps them target and penetrate solid tumors more effectively. The CENDIFOX trial has enrolled 66 patients, including 35 with resectable or borderline resectable pancreatic cancer, 18 with high-grade colon and appendiceal cancer... http://ow.ly/Qasa105ReAy

Today Marengo Therapeutics announced a clinical study collaboration with Gilead Sciences to evaluate Marengo’s Invikafusp alfa (STAR0602) and Gilead’s Trodelvy® in both Metastatic TNBC and Metastatic HR+/HER2- Breast Cancers.    The collaboration will evaluate the combination of Marengo’s first-in-class TCR Vb selective dual T cell agonist, STAR0602 (Invikafusp alfa), with Trodelvy (sacituzumab govitecan-hziy) Gilead’s Trop-2 directed ADC in a new multi-center Phase I/II clinical study (START-002). This innovative combination approach will leverage two unique modalities to target and potentially eradicate cancer cells. Read our press release to learn more: https://lnkd.in/e6kX7Nhb

CEO Vlad Vitoc, MD, MBA shares insights on MAIA’s clinical supply agreement with BeiGene: “Based on excellent pre-clinical results, THIO has been awarded orphan drug designation (ODD) for the treatment of both HCC and SCLC. Along with a third ODD in glioblastoma, the FDA has clearly recognized THIO’s potential as an effective treatment across multiple cancer indications—a remarkable distinction, as most oncology compounds at this stage of development target only one indication. BeiGene’s tislelizumab has similarly demonstrated its potential to deliver clinically meaningful outcomes across a range of tumor types. We are thrilled to partner with BeiGene on these critical studies, two of which focus on addressing the top three most lethal cancers worldwide.” Read more: https://bwnews.pr/4h4O76G

𝐓𝐡𝐚𝐧𝐤 𝐲𝐨𝐮. Since 2022, we've been partnered with ImmunoGen, now part of AbbVie, on a FOLR1 testing initiative, FR-ASSIST, ™ to provide eligible patients with testing for folate receptor alpha (FRα), an actionable biomarker in ovarian cancer. This partnership has helped many patients determine eligibility for a biomarker-driven therapy. Effective December 29th, 2024, the ImmunoGen/AbbVie-sponsored FR-ASSIST™ FOLR1 Ovarian Cancer IHC Testing Program, will be discontinued. Orders received and accessioned between now and December 29 will be processed through the FOLR1 STP as normal. For patient eligibility criteria and requisition forms, visit: https://lnkd.in/g6p7Ags7 NeoGenomics will continue to offer the FOLR1 companion diagnostic IHC test and support oncologists in making informed treatment decisions for their ovarian cancer patients. as a companion diagnostic test: https://lnkd.in/g_sfrFTe We look forward to supporting your patient care with our oncology solutions. Learn more about our test offerings at: https://lnkd.in/gJH7swsP #OvarianCancer #CancerTesting #Oncology

Breast cancer, one of the most common cancers affecting women globally, has seen significant advancements in treatments over the years. These advancements are largely due to rigorous research and evolving regulatory frameworks. Regulatory agencies, such as the FDA and the European Medicines Agency (EMA), have played a critical role in overseeing the safety and efficacy of breast cancer therapies. In this blog we will discuss the key milestones in the regulatory history of breast cancer treatments. Read more here: https://lnkd.in/egetVfRU

Merck discontinues Phase 3 trial for lung cancer combo drug Merck announced the discontinuation of the Phase 3 KeyVibe-008 trial based on the recommendation of an independent Data Monitoring Committee (DMC). The trial is evaluating the investigational fixed-dose combination (coformulation) of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA), Merck’s anti-PD-1 therapy, in combination with chemotherapy compared to atezolizumab in combination with chemotherapy, for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). When compared to patients in the control arm, patients in the vibostolimab and pembrolizumab fixed-dose combination arm experienced a higher rate of adverse events (AEs) and immune-related AEs.

Exciting news in the oncology space! Processa Pharmaceuticals has kicked off a Phase II clinical trial for NGC-Cap, a groundbreaking therapy designed for advanced breast cancer patients. This innovative treatment combines low-dose capecitabine with PCS6422, aiming to enhance the effectiveness of 5-fluorouracil while reducing the side effects commonly associated with standard therapy. The potential of NGC-Cap to shift the paradigm in cancer treatment is immense. By optimizing dosing and enhancing patient tolerance, we could see a future where cancer care is truly personalized. If interim results by mid-2025 reflect the success of previous trials, we may be witnessing the dawn of a new era in breast cancer therapies. Let’s celebrate the strides being made toward more effective and compassionate cancer care! Are you as hopeful about these advancements as I am?

In April, the HER2-targeting antibody–drug conjugate (ADC) trastuzumab deruxtecan was granted accelerated approval by the US Food and Drug Administration for the treatment of unresectable or metastatic HER2-positive solid tumors. After an initial approval in 2019 for this drug for the treatment of patients with unresectable or metastatic HER2-positive breast cancer, the recent tumor-agnostic approval is based on phase 2 studies in the DESTINY clinical trial series: DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. Promising efficacy data had been reported previously in patients with gastric cancer or non–small-cell lung cancer, which led to specific approvals for those cancers, but recent data have shown benefits across many solid-tumor indications — including gynecological cancers, for which there is a particularly strong need for new treatment options.