BioSpace’s Post

Congrats to our residents Clarity Pharmaceuticals! They have just announced positive results from their diagnostic 64Cu-SAR-bisPSMA trial, COBRA, confirming it is safe and highly effective in detecting tumours in prostate cancer patients. Read more below ⬇️ #clinicaltrials #healthtech #deeptech #healthstartup #healthindustry

ENHERTU stands as a cornerstone of AstraZeneca and Daiichi Sankyo’s oncology advancement goals, significantly amplifying the impact of antibody-drug conjugates in the United States. The FDA's approval on April 5, 2024, marks a pivotal moment, endorsing ENHERTU for the treatment of HER2-positive solid tumors in adults who have undergone prior systemic therapy and exhausted other available options. This milestone approval positions ENHERTU as a trailblazing therapy targeting HER2 across various tumor types, making it the first ADC to secure such a comprehensive indication. Developed by Daiichi Sankyo, ENHERTU is an ADC honing in on HER2 and is currently undergoing joint development and commercialization efforts by both Daiichi Sankyo and AstraZeneca. The approval, embracing a tumor-agnostic approach, stems from the efficacy data gathered from 192 adult patients with advanced HER2-positive (IHC 3+) solid tumors, previously treated and deemed unsuitable for surgery. These patients participated in three multicenter phase II trials under the DESTINY clinical development initiative—namely, DESTINY-PanTumor02, DESTINY-Lung01, or DESTINY-CRC02. Across all trials, the primary efficacy endpoint was the confirmed Objective Response Rate, complemented by the Duration of Response . Explore more @ https://lnkd.in/g6KyEiNN #ENHERTU #her2positivesolidtumor #clinicaltrials #clinicalstudies #objectiveresponserate #durationofresponse

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

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)?

FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer On October 3, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. #fda #oncology #immuneoncology #lungcancer #resectable https://lnkd.in/g_JfxqT9

Personalised cell therapies in oncology hold the potential to make cancer treatment more effective and with fewer side effects. They enable patients to be treated individually, targeting their specific cancer. However, developing a personalised medicine, such as a BCMA-targeted CAR-T cell therapy, can require extensive training, preparation and certification. Read this Q&A with Dr Imran Khan, PhD, Vice President, Medical Affairs, Hematology, Johnson & Johnson Innovative Medicine, on European Pharmaceutical Review to learn about the major benefits and current challenges of CAR-T cell therapies: https://lnkd.in/ginskib2 #Oncology #PersonalisedMedicines #CellTherapies #ExecutiveSearch

FDA approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. https://lnkd.in/dzSgWazV

Bispecific antibodies (BsAbs) are revolutionizing hematologic malignancy treatments by enhancing efficacy and reducing toxicity. However, operationalizing these therapies in both academic and community oncology centers presents a significant challenge. Interdisciplinary collaboration is crucial to broaden patient access to these groundbreaking treatments. #Oncology #HealthcareInnovation #Pharmacy #PatientCare #Biotech

📢 FDA approves neoadjuvant/adjuvant Opdivo (nivolumab) for resectable NSCLC ➤ Opdivo, Bristol Myers Squibb Company, approved with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements ➤ Efficacy was evaluated in CHECKMATE-77T (NCT04025879), a randomized, double-blind, placebo-controlled multicenter trial in 461 patients with previously untreated and resectable NSCLC ➤ Median EFS was not reached (95% CI: 28.9, not estimable [NE]) in the nivolumab arm and 18.4 months (95% CI: 13.6, 28.1) in the chemotherapy arm (hazard ratio 0.58 [95% CI: 0.43, 0.78]; p-value 0.00025); adverse reactions were similar to those occurring in other clinical trials of nivolumab with chemotherapy ➤ For this review, FDA collaborated with the Australian TGA, the Brazil's ANVISA, Health Canada, and Israel’s IMoH #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent https://lnkd.in/ekteHqxy