Astrazeneca Plc Stock Price, News & Analysis

Shanghai Cellular Biopharmaceutical Group Ltd. presented promising results for C-CAR031, a novel cell therapy targeting Glypican 3 (GPC3), at the AACR Annual Meeting on April 17, 2023. The Phase I trial indicated that C-CAR031 is well tolerated, showing objective responses in patients with advanced hepatocellular carcinoma (HCC). Out of seven patients, three achieved confirmed partial responses, with substantial tumor shrinkage observed (median -41.4%). The therapy employs a unique safety-enhancing design and aims to provide an effective treatment option for HCC. Ongoing enrollment efforts seek to further confirm these initial findings.

GRAIL’s Methylation Assay demonstrated a remarkable 92% cancer detection rate across six hematologic malignancies with an accuracy of 96% in determining the malignancy subtype. This study, revealed at the AACR Annual Meeting 2023, supports the potential for GRAIL’s methylation platform as a tumor-agnostic, plasma-based test for minimal residual disease (MRD). The technology accurately identified residual cancer in 428 samples, validating its effectiveness post-treatment. The findings suggest a promising avenue for extending patient remission and survival, addressing the challenge of undetected residual cancer that may lead to relapse. GRAIL's collaboration with AstraZeneca also aims at developing companion diagnostic tests for early-stage cancer.

AstraZeneca's IMFINZI® (durvalumab) has demonstrated promising results in the AEGEAN Phase III trial for resectable early-stage non-small cell lung cancer (NSCLC). The trial reported that patients receiving IMFINZI plus neoadjuvant chemotherapy achieved a pathologic complete response (pCR) rate of 17.2%, significantly higher than the 4.3% for chemotherapy alone—a difference of 13% (p=0.000036). Additionally, event-free survival (EFS) showed a 32% risk reduction in recurrence compared to chemotherapy alone. The trial, involving 802 patients across 264 centers globally, aims to provide a new treatment option for lung cancer patients. There were no new safety signals observed. AstraZeneca plans to discuss these data with regulatory authorities in pursuit of approval.

ImaginAb Inc. has announced a poster presentation at AACR 2023 on April 18, 2023, highlighting an independent analysis by AstraZeneca based on the IAB-CD8-201 'iCorrelate' Phase II study. The analysis indicates that CD8 ImmunoPET/CT imaging can differentiate responders from non-responders in patients undergoing immune checkpoint blockade therapy.

The findings suggest a lesion scoring system can provide response evaluations at a median of 35 days, significantly earlier than the 105 days typically required by RECIST. Additionally, it underscores the importance of combining CD8 ImmunoPET and CT measurements for accurate assessments.

ImaginAb’s CD8 ImmunoPET™ aims to enhance drug response evaluations and optimize treatment strategies in immunotherapy trials.

Fusion Pharmaceuticals (FUSN) announced the FDA clearance of IND applications for FPI-2068 and imaging analogue FPI-2107. FPI-2068 is a bispecific targeted alpha therapy (TAT) aimed at delivering actinium-225 to tumors expressing EGFR and cMET, validated targets in cancer treatment. This IND filing marks a critical milestone in the development collaboration with AstraZeneca (AZN), indicating plans for a Phase 1 clinical study. The therapy is intended to enhance tumor specificity and patient screening using corresponding imaging isotopes, potentially increasing therapeutic response rates. The development will be shared equally between Fusion and AstraZeneca through clinical phases, with Fusion managing the initial trial.

AstraZeneca showcased five real-world evidence (RWE) studies from its Cardiovascular, Renal, and Metabolism (CVRM) portfolio at the National Kidney Foundation Spring Clinical Meeting held from April 11-15, 2023. The presented REVOLUTIONIZE I study highlighted the recurrence of hyperkalemia (HK) in chronic kidney disease (CKD) patients following dietary counseling, with rates rising from 37.4% at one month to 56% at six months. Notably, patients with prior HK recurrences experienced shorter intervals between episodes. The study indicates a need for effective treatments like LOKELMA to manage HK in this patient population. AstraZeneca's commitment to developing therapies addressing CKD and HK underscores its strategy to advance patient care.

AstraZeneca announced positive outcomes from the NEURO-TTRansform Phase III trial for eplontersen, targeting hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). Results at 66 weeks indicated that eplontersen met its co-primary endpoints, showing significant improvement in neuropathic disease progression and quality of life measures compared to a placebo. The third endpoint demonstrated significant TTR concentration reduction. Eplontersen, now seeking regulatory approval in the US and Europe, was also accepted for New Drug Application by the FDA, highlighting its potential as a best-in-class treatment amidst urgent medical needs in the field.

AstraZeneca announced positive results from the ADAURA Phase III trial, showing that TAGRISSO (osimertinib) significantly improves overall survival in patients with early-stage EGFR-mutated non-small cell lung cancer (NSCLC) after complete tumor resection. This trial enrolled 682 patients and demonstrated a clinically meaningful survival benefit, reinforcing TAGRISSO's role as a standard treatment in this setting. The safety profile remained consistent with previous studies, with no new major safety concerns raised. AstraZeneca is expanding research on TAGRISSO, including ongoing trials in earlier stages of lung cancer.

AstraZeneca announced positive interim results from the AEGEAN Phase III trial, demonstrating that IMFINZI (durvalumab) combined with neoadjuvant chemotherapy significantly improves event-free survival (EFS) for patients with early-stage non-small cell lung cancer (NSCLC). In the study, IMFINZI was given before and after surgery, showing a clinically meaningful benefit over chemotherapy alone. The results align with previous findings regarding pathologic response rates. The trial continues to evaluate key secondary endpoints such as disease-free survival and overall survival. IMFINZI was well tolerated, and no new safety concerns were reported.