CG Oncology’s Post

AstraZeneca and Daiichi Sankyo US’s ADC improves survival in NSCLC trial AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “Datopotamab deruxtecan is the only investigational therapy to show a clinically meaningful survival improvement in patients with previously treated nonsquamous non-small cell lung cancer versus docetaxel, which has long been unsurpassed in this post-targeted treatment and post-immunotherapy setting. These results reinforce the potential for datopotamab deruxtecan to replace conventional chemotherapy in this late-line setting and underscore our confidence in ongoing trials evaluating this therapy in first-line lung cancer.” - https://lnkd.in/dSFivn-q #clinicaltrials #lungcancer #oncology

🔬 FDA Update: Pembrolizumab for Stomach & Esophageal Junction Cancer 🎯 📌 The FDA has amended its approval of pembrolizumab (Keytruda) for advanced stomach and gastroesophageal junction cancers. Now, its use is specified for tumors with high PD-L1 levels, reflecting findings from the KEYNOTE-811 trial. 💡 This change marks a significant step in personalizing cancer treatment, ensuring the right patients get the most effective therapy. https://ow.ly/U1Zi50QjR3j #Oncology #FDAApproval #CancerTreatment #Pembrolizumab #HealthcareInnovation #ClinicalTrials

Diakonos Oncology reported interim analysis results from the Phase 1 open-label trial evaluating DOC1021 in #glioblastoma multiforme patients The results demonstrated that DOC1021 substantially increased #survival of #glioblastoma multiforme patients well beyond the expected mOS of 12.7 months for patients receiving the SoC. The mOS for the trial of newly diagnosed GBM has not yet been reached with 12-month survival among evaluable patients currently is 88%. These #results were #presented in a poster at the #AACR 2024 The company expects to begin Phase 2 trials of DOC1021 for #glioblastoma multiforme patients within the next year and is conducting two other #clinical #development programs in #pancreatic cancer (NCT04157127) and #angiosarcoma (NCT05799612) Previously, DOC1021 has received Fast Track and Orphan Drug designations from the FDA Source: https://lnkd.in/g-pAbz52

Value-based oncology care organizations will determine "Value" of the therapeutics and this requires the market access function in bio-pharma to demonstrate value with a RWD strategy. Send me a message if you want Coeus to create your strategy with the alignment of clinical pathways, payer policy and RWD. “Rajini Katipamula-Malisetti, MD, executive vice president of Minnesota Oncology, defined value-based cancer care and its importance.” https://lnkd.in/gmjSYZaf

Oncology #RWE provides value across the entire product life cycle, from #clinicalresearch and development to the launch and post-marketing of new treatments. Hear our partners from GSK and Eli Lilly and Company share how they used #RWE to understand unmet need and treatment patterns to support FDA accelerated approval of a new drug for mantle cell lymphoma and assess real-world outcomes and comparative effectiveness post drug launch for patients with recurrent ovarian cancer. Watch the webinar on-demand ➡ https://lnkd.in/eztYBpkf

GSK and AstraZeneca are pushing the envelope with promising immunotherapy advances for endometrial cancer. GSK's Jemperli and AstraZeneca's Imfinzi, both in combination with chemotherapy, show potential to significantly improve patient outcomes by reducing the risk of death and disease progression. Yet, these breakthroughs prompt crucial questions: 🔹 What are the implications for FDA approvals? 🔹 How do we address the challenges posed by treatment-related toxicity? 🔹 In the pursuit of personalized oncology, how can we best tailor treatments to individual tumor profiles? As we navigate these exciting yet complex developments, it's vital to engage in discussions on optimizing cancer care and enhancing patient quality of life. What are your insights on these latest innovations in cancer therapy? #CancerCare #Innovation #Immunotherapy

Out today in Journal of Clinical Oncology - paper looking at barriers to PGx implementation despite the power to IMPROVE patient care (including DPYD testing prior to treatment with 5FU chemotherapy) #patientsafety #5FU #capecitabine #lethaldosing #individualizedpatientcare American Cancer Society Cancer Action Network (ACS CAN) National Comprehensive Cancer Network® (NCCN®) FDA https://lnkd.in/d97cfDyW

AMAZING DATA 👏👏👏: CG Oncology presented in AUA24 that its oncolytic-virus-based therapy - cretostimogene - elicited a 75.2% complete response rate in a late-stage trial among 105 evaluable patients with non-muscle invasive bladder cancer (NMIBC), with 29 patients maintained CR for at least a year. This nice News article mentioned ImmunityBio’s IL-15 agonist and J&J's TAR-200 trial data in NMIBC treatment and the potential combination with Keytruda (Pembrolizumab) to boost cretostimogene’s durability. According to Fierce, CG Oncology plans to file a BLA to the FDA in 2025. 5/3/2024

Congratulations to AstraZeneca! The company's Tagrisso (osimertinib) has just received approval in China for first-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Specifically, this approval applies to patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations. The FLAURA2 Phase III trial demonstrated that Tagrisso plus chemotherapy reduced the risk of disease progression or death by nearly half compared to the standard of care (Tagrisso monotherapy) among Chinese patients. Tagrisso has already been approved as a monotherapy in over 100 countries, including the US, EU, China, and Japan. Its recent combination approval in China marks a significant step forward in personalized lung cancer treatment. #LungCancerTreatment #oncology #lungcancer https://lnkd.in/ggYB4T2d

Busy news day today, so this might fly under your radar: Merck's Keytruda makes progress toward earlier stages of cervical cancer with new Phase III data, showing that it improves overall survival in this indication. Friday's readout comes after the pharma announced last year that Keytruda also significantly benefits PFS in these patients. Keytruda already has two approved indications in cervical cancer. The first is as a combo treatment with chemotherapy, with or without Roche’s Avastin (bevacizumab), for the treatment of persistent, recurrent or metastatic disease. The second is as a monotherapy for metastatic or recurrent cervical cancer that has progressed following chemotherapy. #biotech #biopharma #Keytruda #cervicalcancer