Precision Medicine Online’s Post

Antibody-Drug Conjugate (ADC) is an exciting and growing field. 11 FDA approved ADCs., ten times more in clinical trials and yet so many aspects to investigate. If you are not familiar with the topic here is a didactic review on the technology and the latest trends. https://lnkd.in/eFe-ABdi Having worked on ADCs I highly recommend that read.

Phase 3 EVOKE-01 Study in Metastatic NSCLC Falls Short of Primary Endpoint: Researchers from Gilead remain confident for positive results as they continue the phase 3 EVOKE-03 study in 1L metastatic PD-L1-high NSCLC. #finance #pharmacy #lifesciences

Today, we announced that the U.S. Food and Drug Administration has cleared our Investigational New Drug (IND) application for CTIM-76, a Claudin 6 (CLDN6) x CD3 T cell engaging bispecific antibody. The IND supports the initiation of a Phase 1 dose escalation and expansion #clinicaltrial of CTIM-76 in patients with CLDN6-positive #gynecologic and #testicular #cancers. Context anticipates the enrollment of the first patient in the dose escalation portion of its clinical trial in mid-2024. https://lnkd.in/g9FkTBNP

"Top line results from DESTINY-Breast06 highlight the importance of continuing to challenge current treatment paradigms and established Breast cancer classification" to evolve how HER2 - low and ultralow patients are identified for Enhertu therapy! #Enhertu #precisionmedicine, #BreastCancer, #BreastCancerResearch, #BreastCancerTrials

Interesting take from the FDA to slap a class-wide #blackbox warning for all existing CAR-T products based on post-marketing surveillance risks for secondary T-cell malignancies. This black-box warning is likely going to be quite detrimental to the field and in my view isn't at all justified for some of the approved BCMA/CD19 products which have really given hope and shifted the patient paradigm. Interested to see how Bristol Myers Squibb / Kite Pharma / Novartis will respond and how that might influence current access. What are your thoughts? #cellandgenetherapy https://lnkd.in/e_7t-pAh

I always enjoy reading your takes, Matthias. I see this as a win for #patientsafety. The #blackbox warning for BCMA/CD19 CAR-T products ensures heightened awareness of potential risks among both patients and healthcare providers, leading to better and more informed decision-making and improved monitoring. CAR-T products are still relatively new, which is why #postmarketing AE monitoring is so important in building up our collective understanding of their benefit-risk profiles.

COTA and the FDA will advance #cancerresearch using #realworlddata, focusing on #regulatory decision-making and improving treatment evaluation and availability. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #healthdata

Clinical Trials Updates: FDA Issues Classwide Warning for CAR-T Therapies The FDA is set to issue a classwide black box warning for six commercial CAR-T therapies, including Bristol Myers Squibb’s Abecma and Breyanzi, Kite Pharma’s Yescarta and Tecartus, Johnson & Johnson’s Carvykti, and Novartis’ Kymriah. Companies will have 30 days to respond to the FDA's demand, either by submitting the required changes verbatim, proposing different wording, or providing a rebuttal statement. Failure to comply may result in enforcement actions, including penalties and label changes. Despite the warning, experts, including CAR-T pioneers, suggest continuing the use of commercial CAR-T products based on existing safety information, noting a lower rate of T-cell malignancies compared to some other treatments. However, uncertainty remains regarding how the perceived risk of secondary malignancies might impact the FDA's assessment of benefits and risks as CAR-T therapies move into earlier lines of therapy. For more information on how the companies are planning to address the FDA, please look this up https://lnkd.in/ePWrFJnS #ClinicalTrials #CARTherapies #FDA #DrugSafety #medicalaffairs #clinicaldevelopment

Following three fatalities the FDA has halted a clinical trial involving BioNTech and MediLink ADC due to a significant risk of illness. Here are the key points: Trial Halt: - The FDA has put a temporary hold on a phase 1 clinical trial. - The trial was evaluating an antibody-drug conjugate (ADC) developed by BioNTech and MediLink. - The decision was made due to a serious adverse event observed in a participant. Risk Assessment: - The specific nature of the illness or adverse event has not been disclosed. - However, it was deemed significant enough to warrant an immediate halt to the trial. - The companies are likely working closely with the FDA to assess the situation. Implications: - The halt may impact the development timeline for the ADC. - Safety concerns are a critical factor in drug development, and any potential risks must be thoroughly investigated.

Soon to be published https://lnkd.in/eew5-Ch2 No consistent association between OS, PFS, and drug dose was identified. Fewer severe treatment-related adverse events were observed at lower drug doses. Conclusion: This review provides evidence that enzalutamide, apalutamide or darolutamide could be given at a lower than the standard recommended dose without loss of anti-tumour activity. A prospective near-equivalence randomised trial should be undertaken to compare registered and lower doses of these agents.