AstraZeneca Pharmaceuticals Co. Ltd.

Imfinzi has a generally manageable safety profile, with no new safety signals detected during the trial. Credit: JHVEPhoto via Shutterstock. AstraZeneca has received priority review from the US Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA) for Imfinzi to treat limited-stage small cell lung cancer (LS-SCLC). A regulatory decision on the approval of the therapy is expected by the fourth quarter of this year, under the Prescription Drug User Fee Act. The application is supported by data from the Phase III ADRIATIC clinical trial in LS-SCLC patients whose disease did not progress after treatment with platinum-based concurrent chemoradiotherapy. According to the findings, Imfinzi cut down mortality risk by 27% compared to placebo. Patients treated with Imfinzi had an estimated median overall survival (OS) of 55.9 months, significantly longer than the 33.4 months observed in the placebo group. See Also: Lykos cuts team by 75%, vows to keep MDMA program despite FDA veto Additionally, 57% of patients on Imfinzi were alive at three years, compared to 48% on placebo. The treatment also showed a 24% reduction in the risk of disease progression or death, with a median progression-free survival of 16.6 months for Imfinzi versus 9.2 months for placebo. AstraZeneca’s Imfinzi has a generally manageable safety profile, with no new safety signals detected during the trial. The FDA previously granted Imfinzi breakthrough therapy designation for the treatment of LS-SCLC. AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “This Priority Review reinforces the potential of Imfinzi to transform outcomes for patients as the first and only immunotherapy to demonstrate a survival benefit in limited-stage small cell lung cancer. “There is an urgent need for new treatment options that improve upon the standard of care in this setting, which has not changed in forty years, and we look forward to working with the FDA to bring Imfinzi to patients as quickly as possible.” In July this year, AstraZeneca closed the acquisition of Amolyt Pharma, a company specialising in treatments for rare endocrine diseases. AstraZeneca made a $1.05bn payment for all outstanding shares of Amolyt Pharma, free of cash and debt. The transaction also comprised an upfront payment of $800m and an additional $250m contingent upon reaching a particular regulatory milestone.

AstraZeneca and Daiichi Sankyo’s Enhertu achieved a confirmed ORR of 28.8% and a median PFS of 5.7 months. Credit: Robert Way/Shutterstock. AstraZeneca and Daiichi Sankyo ‘s antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received conditional approval from the China National Medical Products Administration (NMPA) for gastric cancer. The approval allows Enhertu to be used as a single agent for adults with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have undergone a minimum of two previous treatment regimens. The NMPA’s decision was influenced by the positive outcomes of the DESTINY-Gastric06 Phase II trial – an open-label, single-arm study that evaluated Enhertu’s safety and efficacy in Chinese patients with previously treated HER2-positive gastric or GEJ adenocarcinoma. DESTINY-Gastric06’s primary endpoint was the confirmed objective response rate (ORR) as determined by an independent central review. The trial also looked at secondary endpoints: investigator-assessed ORR, progression-free survival (PFS), duration of response, disease control rate, overall survival (OS) and safety. See Also: Madrigal plans to solidify Rezdiffra’s position in MASH despite start being slower than expected Pfizer touts positive topline data for RSV vaccine Abrysvo In the trial, the ADC achieved a confirmed ORR of 28.8% and a median PFS of 5.7 months. Enhertu’s safety profile observed in DESTINY-Gastric06 aligned with previous clinical trials. Supporting evidence for the approval also came from the DESTINY-Gastric01 Phase II trial, which involved patients from Japan and South Korea. In this study, Enhertu significantly improved confirmed ORR and median OS compared to chemotherapy. Enhertu is already sanctioned for use in 45 countries and regions, including Japan, the US and the European Union, for advanced or metastatic gastric cancer. The full approval in China is contingent upon future results from a randomised controlled confirmatory trial that must demonstrate clinical benefit for this patient population. AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “China accounts for more than a third of patients with gastric cancer globally, and most patients are diagnosed with advanced disease. “This approval of Enhertu brings a much-needed, new targeted treatment option to patients with HER2-positive metastatic gastric cancer in China and underscores our commitment to bringing this innovative medicine to more patients across the globe living with HER2-expressing cancers.” Discovered by Daiichi Sankyo, Enhertu is being developed and commercialised jointly with AstraZeneca. In April 2024, the US Food and Drug Administration approved Enhertu for adults with unresectable or metastatic HER2-positive [immunohistochemistry (IHC) 3+] solid tumours .

Tagrisso generated $5.8bn in 2023 for AstraZeneca. Credit: rarrarorro via Shutterstock. AstraZeneca has won approval from the European Commission for Tagrisso (osimertinib) in combination with chemotherapy for non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor mutations (EGFRm) in adults. The tyrosine kinase inhibitor has been approved alongside pemetrexed and platinum-based chemotherapy for the first-line treatment of adults whose tumours have exon 19 deletions or exon 21 (L858R) mutations. Approval is based on positive data from the Phase III FLAURA2 trial (NCT04035486). The trial enrolled 557 patients, showing that Tagrisso and chemotherapy reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso monotherapy, which is the first-line global standard of care. Additionally, median progression-free survival was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus monotherapy. Progression-free survival (PFS) results from a blinded independent central review (BICR) were consistent with the results by investigator assessment, showing 29.4 months median PFS with Tagrisso plus chemotherapy, a 9.5-month improvement over Tagrisso monotherapy. See Also: CAN-3110 by Candel Therapeutics for High-Grade Glioma: Likelihood of Approval ICTCAR-028 by Innovative Cellular Therapeutics for Hematological Tumor: Likelihood of Approval The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approving Tagrisso last month. The drug earned AstraZeneca $5.8bn in sales last year, as per the company’s financials. According to GlobalData’s Pharma Intelligence Centre, Tagrisso is forecast to generate $7.4bn in 2030. GlobalData is the parent company of Pharmaceutical Technology. Currently, AstraZeneca’s Imfinzi (durvalumab) is the standard of care for patients with stage III EGFRm NSCLC, but studies have shown that administering immunotherapy to patients with EGFRm is associated with very low response rates. In the announcement accompanying the approval, AstraZeneca oncology business executive vice president Dave Fredrickson said: “This approval reinforces Tagrisso as the backbone therapy in EGFR-mutated lung cancer either as monotherapy or in combination with chemotherapy. This is especially important for those with more aggressive disease, including patients whose cancer has spread to the brain and those with L858R mutations.” Tagrisso combined with chemotherapy is already approved for the first-line treatment of locally advanced or metastatic EGFRm NSCLC in the USA, China, Japan, and other countries. It is also approved as monotherapy in more than 110 countries, including in the USA, EU, China, and Japan, for locally advanced or metastatic EGFRm NSCLC, EGFR T790m positive NSCLC, and as an adjuvant therapy for early-stage EGFRm NSCLC.