Astrazeneca Plc - AZN STOCK NEWS

AstraZeneca's supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib) has received Priority Review from the FDA for treating adult patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) post-chemoradiotherapy. The decision is based on the LAURA Phase III trial, which indicated a significant extension in median progression-free survival (PFS) of more than three years. TAGRISSO was also granted Breakthrough Therapy Designation for this setting. The FDA action date is anticipated in Q4 2024. TAGRISSO showed an 84% reduction in the risk of disease progression or death compared to placebo, with a PFS of 39.1 months versus 5.6 months with placebo. Safety profiles were consistent with no new concerns identified. Additionally, TAGRISSO is approved in over 100 countries for various indications in treating EGFR-mutated NSCLC.

I-Mab (NASDAQ: IMAB) has announced the appointment of Dr. Phillip Dennis as Chief Medical Officer, effective June 17, 2024. Dr. Dennis will lead I-Mab's global clinical development and join the Executive Leadership Team. With two decades of oncology drug development experience, including key roles at Sanofi and AstraZeneca, Dr. Dennis brings significant expertise. His appointment aims to advance I-Mab's clinical pipeline, particularly for treatments like uliledlimab, givastomig, and ragistomig. Before his industry roles, Dr. Dennis was a professor at Johns Hopkins University and a senior investigator at the US National Cancer Institute.

Nucleus RadioPharma announced the closing of a Series A extension funding round with AstraZeneca as a new investor. The funding aims to expand Nucleus's development, supply, and commercial manufacturing capabilities for targeted radiotherapies and theranostics, improving global patient access. Dr. Tyrell Rivers, Executive Director of Corporate Ventures at AstraZeneca, joined Nucleus’s Board of Directors. The precision of theranostics, combining diagnostics and therapeutics through radiotracers, offers a promising treatment for metastatic cancers, minimizing side effects compared to traditional methods. Charles S. Conroy, CEO of Nucleus, highlighted the remarkable effectiveness and safety of these drugs. The funding will facilitate large-scale production, addressing the challenges of the perishable nature of radiopharmaceuticals and enhancing their accessibility for cancer treatment worldwide.

AbelZeta Pharma has reported preliminary data from its first human trial of C-CAR031, a GPC3-targeting CAR-T therapy for advanced hepatocellular carcinoma (HCC), presented at the 2024 ASCO Annual Meeting. The study showed a 91.3% disease control rate (DCR) and a 56.5% objective response rate (ORR) across all dose levels, with an ORR of 75.0% at dose level 4. Tumor reductions were observed in 91.3% of patients, with a median reduction of 42.2%. The median overall survival (mOS) was 11.14 months. Safety data indicated manageable side effects, with no dose-limiting toxicity or ICANS observed, and most cytokine release syndrome cases were mild.

AstraZeneca's TAGRISSO® (osimertinib) demonstrated a significant improvement in progression-free survival (PFS) for patients with unresectable, Stage III EGFR-mutated lung cancer, as shown in the LAURA Phase III trial. In the trial, TAGRISSO reduced the risk of disease progression or death by 84% compared to placebo (HR 0.16; 95% CI 0.10-0.24; p<0.001). Median PFS was 39.1 months for TAGRISSO versus 5.6 months for placebo. The trial included 216 patients and results were presented at the 2024 ASCO Annual Meeting and published in The New England Journal of Medicine. The study noted a favorable trend in overall survival, though data is still maturing. Safety results were consistent with previous studies, with Grade 3 or higher adverse events in 35% of TAGRISSO patients. TAGRISSO is already approved in over 100 countries for various indications. The drug's efficacy cements its role as a critical therapy in managing EGFR-mutated NSCLC.

AstraZeneca's IMFINZI® (durvalumab) has shown significant survival benefits in a global Phase III ADRIATIC trial for -stage small cell lung cancer (LS-SCLC). The trial revealed that IMFINZI reduced the risk of death by 27% compared to placebo, with an estimated median overall survival (OS) of 55.9 months versus 33.4 months for placebo.

Additionally, 57% of patients treated with IMFINZI survived at least three years compared to 48% on placebo. The drug also reduced the risk of disease progression or death by 24%, with a median progression-free survival (PFS) of 16.6 months versus 9.2 months for placebo.

The trial results were consistent across various patient subgroups, and the safety profile of IMFINZI was manageable with no new safety signals. These findings were announced at the 2024 ASCO Annual Meeting, positioning IMFINZI as a potential new standard of care for LS-SCLC.

ENHERTU® demonstrated a median progression-free survival (PFS) of 13.2 months in HR positive, HER2 low and ultralow metastatic breast cancer patients following one or more lines of endocrine therapy, as shown in the DESTINY-Breast06 trial. The results showed a 38% reduction in the risk of disease progression or death compared to chemotherapy, with a statistically significant improvement in PFS. The overall response rate (ORR) was 57.3% with ENHERTU versus 31.2% with chemotherapy. These findings suggest that ENHERTU could become a new standard of care for this patient group. The trial also highlighted the safety profile of ENHERTU, which was consistent with previous trials.

ENHERTU® (fam-trastuzumab deruxtecan-nxki), developed by AstraZeneca and Daiichi Sankyo, has shown promising results in the DESTINY-Breast06 Phase III trial for HR-positive, HER2-low and HER2-ultralow metastatic breast cancer. The trial indicated a median progression-free survival (PFS) of 13.2 months versus 8.1 months for chemotherapy, reducing the risk of disease progression or death by 38% (HR 0.62; 95% CI: 0.51-0.74; p<0.0001). Data also confirmed a higher objective response rate of 57.3% for ENHERTU compared to 31.2% with chemotherapy. No new safety concerns emerged, but interstitial lung disease was noted in 11.3% of patients. Additional data from DESTINY-Breast03 and DESTINY-Breast07 reinforce ENHERTU's potential as a standard treatment in earlier lines for HER2-positive breast cancer.

Compugen has announced that it will receive a $5 million milestone payment from AstraZeneca following the dosing of the first patient in the Phase 3 TROPION-Lung10 trial. This trial evaluates the efficacy and safety of rilvegostomig, a PD-1/TIGIT bispecific antibody, as monotherapy and in combination with datopotamab deruxtecan for first-line treatment of non-squamous non-small cell lung cancer patients with high PD-L1 expression. The trial is expected to enroll approximately 675 patients across 14 countries. This milestone is part of Compugen's strategy to expand its pipeline through partnerships, following a previous $10 million payment related to the ARTEMIDE-Biliary01 Phase 3 trial.