Astrazeneca Plc - AZN STOCK NEWS

ULTOMIRIS (ravulizumab-cwvz) has demonstrated zero adjudicated relapses over a median treatment duration of 73 weeks in the Phase III CHAMPION-NMOSD trial for adults with anti-AQP4 antibody-positive NMOSD. The trial revealed a statistically significant reduction in relapse risk, achieving its primary endpoint concerning time to first relapse. The safety profile was consistent with previous studies, with ongoing long-term treatment for 56 patients. Data will be submitted to health authorities to expedite ULTOMIRIS availability for the NMOSD community.

AstraZeneca and Daiichi Sankyo's ENHERTU has received FDA approval for earlier use in treating unresectable or metastatic HER2-positive breast cancer. This decision is based on the DESTINY-Breast03 Phase III trial results, which showed a 72% reduction in disease progression or death compared to trastuzumab emtansine. The approval broadens ENHERTU's indication to patients who recur within six months of prior anti-HER2 therapies. The approval initiates a $100 million milestone payment from AstraZeneca to Daiichi Sankyo.

Daiichi Sankyo and AstraZeneca’s ENHERTU has received FDA approval for earlier use in treating HER2 positive metastatic breast cancer. The approval follows the DESTINY-Breast03 trial, proving ENHERTU reduces disease progression or death risk by 72% compared to T-DM1. With a median progression-free survival not reached for ENHERTU versus 6.8 months for T-DM1, this milestone expands treatment options for patients. Additionally, a milestone payment of $100 million is due from AstraZeneca to Daiichi Sankyo following this approval.

AstraZeneca's supplemental Biologics License Application for Imfinzi (durvalumab) has been accepted for Priority Review in the US for treating locally advanced or metastatic biliary tract cancer (BTC). The FDA's decision is anticipated in Q3 2022. The application is based on the TOPAZ-1 Phase III trial, which revealed that Imfinzi combined with chemotherapy reduced death risk by 20% compared to chemotherapy alone. This new immunotherapy approach aims to improve treatment outcomes for BTC patients, who currently face poor prognoses.

Innate Pharma announced the first patient dosing in the Phase 3 PACIFIC-9 trial for patients with unresectable Stage III non-small cell lung cancer (NSCLC). This trial evaluates the efficacy of durvalumab in combination with monalizumab or oleclumab. The initiation of the trial triggers a $50 million milestone payment from AstraZeneca to Innate, strengthening its cash position. The PACIFIC-9 study aims to assess whether these combinations improve treatment outcomes following standard platinum-based concurrent chemoradiation therapy.

ULTOMIRIS (ravulizumab-cwvz) has received FDA approval for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-AChR antibody positive, representing 80% of gMG cases. This approval, stemming from the CHAMPION-MG Phase III trial, showed significant improvement in daily living activities. ULTOMIRIS is the first long-acting C5 complement inhibitor approved for gMG, enabling dosing every eight weeks. The trial involved 175 patients and presented a favorable safety profile, aligning with prior studies in similar conditions.

AstraZeneca and Daiichi Sankyo's ENHERTU received Breakthrough Therapy Designation in the US for treating HER2-low metastatic breast cancer. This designation is based on positive results from the DESTINY-Breast04 trial, which showed significant improvements in progression-free and overall survival compared to chemotherapy. ENHERTU, which has now secured five BTDs, aims to address the unmet need in breast cancer treatment, especially for patients with lower HER2 expression. The FDA’s expedited review process highlights the potential benefits for patients in urgent need of new therapies.

Daiichi Sankyo and AstraZeneca's ENHERTU has received its fifth Breakthrough Therapy Designation (BTD) from the FDA for treating adult patients with unresectable or metastatic HER2 low breast cancer. This designation follows positive results from the DESTINY-Breast04 trial, which demonstrated significant improvements in progression-free survival and overall survival compared to standard chemotherapy. The safety profile of ENHERTU remains consistent with previous trials. This designates ENHERTU as a potential game-changer for patients with lower HER2 expression, addressing a critical unmet medical need.

AstraZeneca announced that the FDA has accepted its Biologics License Application for a single priming dose of tremelimumab combined with Imfinzi for treating unresectable hepatocellular carcinoma (HCC). This STRIDE regimen aims to improve overall survival, supported by the Phase III HIMALAYA trial results showing a 22% reduction in death risk compared to sorafenib. The FDA decision is expected in Q4 2022. HCC is a major global health concern, with about 26,000 new advanced cases annually in the US. AstraZeneca continues to explore additional cancer treatment strategies.