Tristan Cesar Mañalac’s Post

📢 Seagen's Tivdak confirms benefit in recurrent or metastatic cervical cancer with disease progression on or after chemotherapy; AA PMR fulfilled (Pfizer) ➤ Efficacy was evaluated in innovaTV 301 (NCT04697628), an open-label, active-controlled, multicenter, randomized trial that enrolled 502 patients with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens, including chemotherapy with or without bevacizumab and/or an anti-PD-(L)-1 agent ➤ Median OS was 11.5 months (95% CI: 9.8, 14.9) vs. 9.5 months (95% CI: 7.9, 10.7) in the chemotherapy arm (HR 0.70 [95% CI: 0.54, 0.89] p-value 0.0038) ➤ Trial’s results fulfill the post-marketing requirement of the FDA's 2021 accelerated approval for this indication #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent https://lnkd.in/g_ADYadi

Bristol Myers Squibb presented interim findings from the Phase III CheckMate-8HW trial, demonstrating a significant improvement in progression-free survival (PFS) with the combination of #Opdivo (nivolumab) and #Yervoy (ipilimumab) versus chemotherapy in the first-line treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic #colorectalcancer (mCRC). https://lnkd.in/dYGatu4s #BMS #cancer #clinicalresearch #clinicaltrials #medicalaffairs #oncology #pharmaceuticals

📢 FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer (IMFINZI® (durvalumab) HCP, AstraZeneca) ➤ Median EFS was not reached (95% CI: 31.9, not estimable [NE]) in the durvalumab arm and 25.9 months (95% CI: 18.9, NE) in the placebo arm (hazard ratio 0.68 [95% CI: 0.53, 0.88]; p-value=0.0039). ➤ pCR rate was 17% (95% CI: 13, 21) and 4.3% (95% CI: 2.5, 7) in the durvalumab and placebo arms, respectively. ➤ At the time of the prespecified interim analyses, OS was not formally tested for statistical significance; however, a descriptive analysis revealed no clear detriment #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent https://lnkd.in/eUap2Uu3

Congratulations to BeiGene for the FDA approval of Tevimbra (tislelizumab) to treat advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody (mAb) which minimizes binding to macrophage Fcγ receptors, thus facilitating the patient’s immune cells to recognize and fight tumors. Esophageal cancer is the sixth most common cause of cancer fatalities in the world, with over two-thirds of patients having advanced or metastatic disease at the time of diagnosis. Several clinical trials have taken place for use as both a monotherapy and in combination with other regimens, and over 750,000 individuals prescribed.   Read the press release here: https://lnkd.in/djDr4xyY   #Biointron #Antibodies #Immunotherapy #PharmaNews #FDA #Oncology

Bold Therapeutics Inc. presented positive Phase 2 results for BOLD-100 in treating advanced metastatic #colorectal #cancer at the #ASCOGI2024 Combined with #FOLFOX, BOLD-100 showed promising efficacy and safety. The drug, achieved a median progression-free survival of 3.9 months and an overall survival of 9.6 months. #colorectalcancer Jim Pankovich, EVP of Clinical Development at Bold Therapeutics, expressed optimism about the unexpectedly favorable safety profile of BOLD-100. He noted, "Not only are we encouraged with BOLD-100's efficacy, but we are excited about BOLD-100's unexpectedly favorable safety profile, which has allowed patients to remain on treatment considerably longer than originally expected and thus maximizes the impact of the treatment combination." By Tracy Mokwe https://lnkd.in/dVDYMnPV

Clarity Pharmaceuticals and 64Cu-SAR-bisPSMA, what is new?? Bis!! Take a look how bisPSMA increase and prolong PSMA uptake, will this new approach get better results in Theranostics increasing lesion dose (Gy)?

Clarity is excited to share the initial results from the COBRA trial where 64Cu-SAR-bisPSMA was found to be safe and highly effective in detecting prostate cancer (PC) lesions in patients with biochemical recurrence (BCR).   In trial participants where standard of care imaging was unable to detect any lesions, up to approximately 60% had lesions identified by same-day 64Cu-SAR-bisPSMA imaging and up to 80% on next-day imaging, with high specificity on both days. The COBRA trial now formally expands the potential use of 64Cu-SAR-bisPSMA into the BCR of PC setting with the added benefit of next-day imaging and we have commenced planning a Phase 3 trial in this patient population.   #prostatecancer #PSMA #radiopharmaceuticals #TCT

Exciting News! Adaptimmune receives U.S. FDA accelerated approval of TECELRA® (afamitresgene autoleucel) for advanced MAGE-A4+synovial sarcoma in adults with certain HLA types who have received prior chemotherapy. This is the first approved TCR-T cell therapy, and the first approved engineered cell therapy for solid tumor! The approval of TECELRA was based on results of the SPEARHEAD-1 (Cohort 1) trial, which included 44 patients. The major efficacy outcome was overall response rate (ORR) determined by independent review and supported by duration of response. TECELRA treatment resulted in an ORR of 43% with a complete response rate of 4.5%. The median duration of response was 6 months (95% CI: 4.6, not reached). Among patients who were responsive to the treatment, 39% had a duration of response of 12 months or longer. Also see this The Lancet paper for detailed SPEARHEAD-1 trial data: Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial. Published:March 27, 2024 (https://lnkd.in/ePeYMrGz)

🌟Happy to share our latest publication of the first 30 patients treated with TLD-1🌟 Our clinical findings demonstrate TLD-1's significant potential in making cancer care better. This novel liposomal PEGylated doxorubicin has shown a favorable safety profile, particularly in patients with advanced breast cancer, where we observed a noteworthy objective response rate (ORR) of 23.1%. Notably, TLD-1 was well-tolerated at a dose of 40 mg/m² every 3 weeks, showcasing its potential as a more efficacious and safer alternative in oncology. TLD-1's innovation lies in its design to enhance the pharmacokinetic profile, featuring a smaller nanoparticle diameter for improved tumor uptake and a high lipid-to-drug ratio with dense surface PEGylation. These characteristics are crucial for maximizing therapeutic efficacy while minimizing adverse effects, marking a significant step forward in our fight against cancer. I extend my deepest gratitude to the patients and their families for participating in this study. A big thanks also to our collaborator SAKK Swiss Group for Clinical Cancer Research and our in-house team at InnoMedica Holding AG for their relentless support. Link here 👇 https://lnkd.in/d6PiAmbh Patent here 👇 https://lnkd.in/daayKNPm A second manuscript is in the making and coming out soon, comparing the pharmacokinetics of TLD-1 and Caelyx/Doxil head-to-head in an intrapatient setting, as well as safety and efficacy with continued TLD-1 treatment. We are still far away from our overarching goal to innovate multiple broadly used cancer drugs (such as vinca alkaloids, patin-derivatives, alkylating agents, contrasting agents, etc.) with the nanodrug delivery system used here for TLD-1. Nevertheless, we now have a solid anchor point in the clinics and that already constitutes a very valuable advancement, as it significantly accelerates and de-risks any follow-on development program. If you want to try this liposome system in your own research (preclinical & clinical), reach out to me or someone at InnoMedica. Contact here 👇 https://lnkd.in/efs576yb #Cancer #innovation #BreastCancer #Nanomedicine #Oncology #research #drugdelivery #chemotherapy

As the finalized FDA guidance on oncology dose optimization was published last week (https://lnkd.in/ek8TanmM), we see dose optimization in real action: lower dose selected as the optimal dose for T-DXd in HER2+ mCRC. https://lnkd.in/eR68fcPS