AstraZeneca PLC - AZN STOCK NEWS

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.

The TROPION-Lung01 phase 3 trial results indicate that datopotamab deruxtecan (Dato-DXd), developed by Daiichi Sankyo and AstraZeneca (AZN), shows a clinically meaningful improvement in overall survival (OS) for patients with nonsquamous non-small cell lung cancer (NSCLC) compared to docetaxel, the current standard chemotherapy.

Although the OS improvement did not reach statistical significance across all trial participants, it was notable in the pre-specified subgroup of nonsquamous NSCLC patients. The trial previously met its primary endpoint of progression-free survival (PFS), demonstrating a significant improvement in PFS and overall response rates compared to docetaxel.

The safety profile of Dato-DXd was favorable, with fewer dose reductions and no new safety concerns. These results support ongoing regulatory reviews in the U.S. and EU, aiming to establish Dato-DXd as a new standard treatment for advanced metastatic nonsquamous NSCLC.

AbelZeta Pharma, a clinical-stage biopharmaceutical company, has published an abstract of its C-CAR031 study for the ASCO 2024 Annual Meeting. The study focuses on hepatocellular carcinoma (HCC) and involves 24 patients. AbelZeta plans to present safety and preliminary efficacy data at the meeting in Chicago from May 31 to June 4, 2024. The oral presentation is scheduled for June 3, 2024, at 9:45 AM-11:15 AM CDT. More details can be found on the ASCO official website.

AstraZeneca and Alexion will present 14 studies on amyloidosis therapies at the 2024 International Symposium on Amyloidosis from May 26-30. Key presentations include new subgroup analyses for eplontersen, approved by the FDA in December 2023, and data on ALXN2220 and anselamimab in Phase III trials. The symposium will also feature real-world evidence and patient outcomes from various studies. AstraZeneca aims to advance the science of amyloidosis and improve patient outcomes. Important findings include the use of ALXN2220 for cardiac amyloid removal and the prevalence of phenotypes in ATTR amyloidosis. The company is also seeking regulatory approval for WAINUA in Europe.