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AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) has been recommended by the National Institute for Health and Care Excellence (NICE) as part of a combination treatment for advanced breast cancer. The health technology assessment agency has recommended in final draft guidance that the drug be used in combination with AZ’s endocrine therapy Faslodex (fulvestrant) to treat adults on the NHS in England and Wales with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with at least one PIK3CA, AKT1 or PTEN gene alteration. Patients eligible for the therapy will also have experienced disease recurrence or progression after a CDK4/6 inhibitor plus an aromatase inhibitor. Approximately 56,800 new cases of breast cancer are diagnosed in the UK each year, and NICE estimates that around 1,100 patients will benefit from AZ’s combination. Given as a twice-a-day tablet, Truqap works by blocking the effects of proteins called ATK kinases, which allow cancer cells to grow and multiply. The Medicines and Healthcare products Regulatory Agency approved the combination in July 2024 after it was shown in the late-stage CAPItello-291 trial to reduce the risk of disease progression or death by 50% compared with Faslodex alone. NICE then requested further analyses from the company following its first committee meeting about the long-term effectiveness of Truqap compared with existing treatments. Helen Knight, director of medicines evaluation at NICE, said: “People with advanced breast cancer would value treatments like [Truqap] that can be given when limited options exist and because it may delay the need for chemotherapy and its associated side-effects. “We are therefore pleased the company has worked with us so that we are able to recommend this promising new treatment as a good use of NHS resources and value for money for taxpayers.” The science behind Truqap was discovered by AZ after a partnership with Astex Pharmaceuticals and collaboration with the Institute of Cancer Research (ICR) and Cancer Research Technology. Tom Keith Roach, president, AZ UK said: “[Truqap] is a UK-discovered medicine for eligible patients with advanced breast cancer. “The partnership between AZ, the ICR and Cancer Research Technology underscores the potential of UK life sciences, which we are working with [the] government to unlock on behalf of patients and the UK growth agenda.”

AstraZeneca (AZ) has received two separate recommendations from the National Institute for Health and Care Excellence (NICE) for use of its lung cancer drugs Tagrisso (osimertinib) and Imfinzi (durvalumab) in NHS patients across England and Wales. Tagrisso has been recommended for use as an adjuvant treatment following complete resection in adults with stage 1B to 3A non-small cell lung cancer (NSCLC) whose tumours express epidermal growth factor (EGFR) exon 19 deletions or exon 21 substitution mutations. Meanwhile, Imfinzi (durvalumab) has been recommended for use in combination with etoposide plus either carboplatin or cisplatin to treat adults with untreated extensive-stage small cell lung cancer (SCLC). Approximately 49,200 people are diagnosed with lung cancer in the UK every year. NSCLC is the most common form of the disease, accounting for around 85% of cases, while SCLC represents approximately 15% of all diagnoses. NICE’s decision on Tagrisso was based on positive results from the late-stage ADAURA trial, in which treatment with the drug after surgery reduced the relative risk of disease recurrence or death by 83% compared to placebo in patients with stage 2 to 3A EGFR-mutated NSCLC. Survival without disease recurrence at two years was 90% for the Tagrisso cohort and 44% for placebo and, among patients with stage 1B to 3A disease, 89% of those being treated with AZ’s drug were alive and disease-free at 24 months compared to 52% in the placebo group. Results from the phase 3 CASPIAN trial supported the health technology assessment agency’s recommendation of Imfinzi. A two-year follow-up analysis of the study showed that first-line treatment with Imfinzi plus platinum chemotherapy demonstrated significant and clinically meaningful improvements in overall survival in patients with extensive-stage SCLC versus chemotherapy alone, and updated results from the trial showed that the Imfinzi combination reduced the risk of death by 29% compared with chemotherapy alone at three years. Tom Keith-Roach, president, AZ UK, said: “This is fantastic news for lung cancer patients. We are proud that these decisions by NICE mean we’ve had 28 positive recommendations by NICE and the Scottish Medicines Consortium since 2021 across multiple cancer types and stages.” The latest recommendations come less than two weeks after the company’s Lynparza (olaparib) was recommended by NICE to treat adults with HER2-negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations after chemotherapy.

AstraZeneca’s (AZ) Imfinzi (durvalumab) regimen has been approved by the US Food and Drug Administration (FDA) to treat a subset of adults with resectable non-small cell lung cancer (NSCLC). The anti-PDL1 antibody has been authorised for use alongside neoadjuvant chemotherapy before surgery and then as an adjuvant monotherapy after surgery. Patients eligible for the regimen will have resectable early-stage (stage 2A to 3B) NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. The FDA’s decision, which means that Imfinzi is now approved in the US to treat both resectable and unresectable NSCLC, was supported by positive data from the late-stage AEGEAN trial. According to a planned interim analysis of event-free survival, patients treated with the regimen achieved a 32% reduction in the risk of recurrence, progression or death compared to neoadjuvant chemotherapy alone. The combination also demonstrated a pathologic complete response rate of 17.2% versus 4.3% for patients receiving neoadjuvant chemotherapy only. Approximately 235,000 people are expected to be diagnosed with lung cancer in the US this year, with NSCLC accounting for the majority of cases. Up to 30% of all NSCLC patients are diagnosed early enough to have surgery with curative intent. However, most of those with resectable disease will develop recurrence. Dave Fredrickson, executive vice president, oncology business unit, AZ, said: “[This] approval of Imfinzi in resectable early-stage lung cancer builds on its strong foundation of changing clinical practice in unresectable stage 3 disease. “We remain committed to bringing novel approaches like AEGEAN to early lung cancer settings where cure is the goal of treatment.” The approval comes just over a month after AZ received marketing authorisation from the Medicines and Healthcare products Regulatory Agency for the Imfinzi/chemotherapy regimen in resectable NSCLC. David Harland, head of oncology medical affairs, AZ UK, said the approval “[marked] a major advancement and opens a new chapter in the treatment of resectable NSCLC”. Regulatory applications are also currently under review in the EU and several other countries for the use of Imfinzi in this setting.