AstraZeneca reports CLL trial success with Calquence combo
AstraZeneca PLC (LSE/STO/Nasdaq: LON:) today announced positive results from its Phase III AMPLIFY trial, demonstrating that its drug Calquence, when used in combination with venetoclax, with or without obinutuzumab, significantly improved progression-free survival (PFS) in patients with first-line chronic lymphocytic leukemia (CLL).
The trial also indicated a favorable trend in overall survival (OS), although the data is not yet mature and will continue to be a secondary endpoint of the study.
The AMPLIFY trial compared the efficacy of the Calquence combination against standard chemoimmunotherapy in previously untreated adult patients with CLL. The safety profile of the treatment was consistent with previous findings, with no new safety concerns and low rates of cardiac toxicity observed.
The trial’s findings are particularly relevant as CLL is the most common type of leukemia in adults globally, and the number of patients is expected to increase. The standard of care currently treats approximately 40,000 patients in the first-line setting annually. CLL is an incurable cancer, but patients often live with the disease for many years, sometimes requiring continuous treatment.
Dr. Jennifer R. Brown, the principal investigator of the trial, emphasized the significance of the results, noting the potential of the fixed-duration treatment to improve patients’ quality of life by allowing treatment breaks, and reducing long-term adverse events and drug resistance.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca (NASDAQ:), highlighted the potential of including a BTK inhibitor in a fixed-duration regimen and the company’s leadership in CLL treatment. If approved, Calquence could become the only second-generation BTK inhibitor available as both a continuous and fixed-duration treatment.
The trial results are expected to be presented at an upcoming medical meeting and will be shared with global regulatory authorities. The AMPLIFY study enrolled patients from 2019 to 2021 and continued through the COVID-19 pandemic, a period during which patients with blood cancer faced a disproportionately high risk of severe outcomes from the virus.
Calquence is currently approved for the treatment of CLL and small lymphocytic lymphoma in various countries and is being evaluated for multiple B-cell blood cancers as part of AstraZeneca’s extensive clinical development program.
This news is based on a press release statement.
In other recent news, AstraZeneca has reported promising developments in both their financial performance and clinical trials. The company’s total revenue has seen an 18% increase, climbing to nearly $13 billion in the second quarter, with core operating profit reaching $8.4 billion. AstraZeneca’s revised full-year guidance now anticipates mid-teens percentage increases in both total revenue and core EPS.
In the realm of clinical trials, AstraZeneca’s drug Imfinzi (durvalumab) has shown potential for treating resectable non-small cell lung cancer (NSCLC), based on positive results from the AEGEAN Phase III trial. The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recognized Imfinzi’s potential, noting a 32% reduction in the risk of disease recurrence or death compared to chemotherapy alone.
Furthermore, the company’s strategic focus includes over 40 phase 3 trials expected to be reported before the end of 2025. This is in line with their 2030 goals of achieving $80 billion in total revenue and launching at least 20 new medicines.
InvestingPro Insights
AstraZeneca PLC’s recent announcement of positive trial results for Calquence has the potential to further strengthen its position in the pharmaceutical industry. Real-time data from InvestingPro shows that AstraZeneca’s market cap stands at a robust 246.71 billion USD, reflecting the company’s significant size and influence. The company’s P/E ratio, at 38.13, may seem high, but when adjusted for the last twelve months as of Q2 2024, it presents a more moderate figure of 26.92. This suggests that while the company is trading at a high earnings multiple, its profitability is recognized by the market.
InvestingPro Tips indicate that AstraZeneca is a prominent player in the Pharmaceuticals industry and has maintained dividend payments for 32 consecutive years, showcasing its commitment to shareholder returns. Additionally, the company’s stock generally trades with low price volatility, which could appeal to investors looking for stability in their portfolio. However, three analysts have revised their earnings downwards for the upcoming period, which is a point for potential investors to consider.
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