After three years, 85.9% of patients treated post-surgically with Lynparza were free of invasive breast cancer and second cancers compared to 77.1% of the placebo group.
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Throughout the past few days, AstraZeneca has been presenting data at the American Society of Clinical Oncology (ASCO) Annual meeting that reaffirms the company’s commitment to redefine cancer care.
In a pre-ASCO panel co-led by The Cancer Support Community, AstraZeneca asked the million-dollar question: Are we ready to talk cure in cancer? While the panelists, which included oncologists, researchers and AstraZeneca executives, didn’t come to a clear conclusion, the company is making headway in at least two indications: post-surgery, high-risk HER2-negative early breast cancer and chronic lymphocytic leukemia (CLL).
During ASCO’s plenary session on Sunday, data was presented from the OlympiA Phase III trial showing that LYNPARZA® (olaparib), the first poly ADP ribose polymerase (PARP) inhibitor to show clinical benefit in the adjuvant setting for early breast cancer, reduced the risk of invasive breast cancer recurrences, second cancers, or death by 42%.
After three years, 85.9% of patients treated post-surgically with Lynparza were free of invasive breast cancer and second cancers compared to 77.1% of the placebo group.
“Patients with early-stage breast cancer who have inherited BRCA mutations are typically diagnosed at a younger age compared to those without such a mutation. Olaparib has the potential to be used as a follow-on to all the standard initial breast cancer treatments to reduce the rate of life-threatening recurrence and cancer spread for many patients identified through genetic testing to have mutations in these genes,” said Andrew Tutt, OlympiA trial steering committee chair and professor of Oncology at The Institute of Cancer Research, London and Kings College London.
The blockbuster therapy, which is being jointly developed and commercialized by AstraZeneca and Merck in a global strategic oncology collaboration struck in 2017, also met its key secondary endpoint, reducing the risk of distant disease recurrence or death by 43%.
“New results for LYNPARZA® (olaparib) and IMFINZI® (durvalumab) continue to validate our strategy of treating cancer early in settings with curative intent, and data for CALQUENCE deliver on our commitment to improve the patient experience by demonstrating efficacy with safe, tolerable medicines,” said Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, prior to the conference.
On Monday, AstraZeneca will present final data from its ELEVATE-RR Phase III trial of Bruton’s tyrosine kinase (BTK) inhibitor, CALQUENCE® (acalabrutinib) in adults with previously treated chronic lymphocytic leukemia (CLL) at high risk for progression. In comparison with Imbruvica (ibrutinib), Calquence demonstrated significantly lower atrial fibrillation, fewer cardiac events, and fewer discontinuations.
Calquence met its primary endpoint, showing progression-free survival (PFS) non-inferiority versus ibrutinib with a median PFS of 38.4 months in both arms. Patients treated with Calquence were 6.6 times less likely to develop all-grade atrial fibrillation compared with those treated with ibrutinib. (9.4% versus 16.0%).
Adverse events led to treatment discontinuation in 14.7% of patients on Calquence, while 21.3% discontinued treatment with ibrutinib.
“We do not presently know or understand why some BTK inhibitors might be more prone to triggering cardiac adverse events such as hypertension or atrial fibrillation. However, additional studies presented within the summer meetings demonstrate that second-generation BTK inhibitors have fewer cardiac adverse events,” Dr. Jeff Sharman, medical director of hematology research for US Oncology at the Willamette Valley Cancer Institute & Research Center, told BioSpace.
Sharman explained that B-cell receptor signaling, which is vital to the survival of chronic lymphocytic leukemia cells, is impeded by BTK inhibitors, resulting in reduced proliferation and increased cell death among the malignant cells. CLL is the most common form of adult-onset leukemia.
ELEVATE-RR is the first head-to-head Phase III trial of two Bruton’s tyrosine kinase inhibitors (TKIs) in CLL. Calquence won U.S. Food and Drug Administration (FDA) approval in this indication, as well as for small lymphocytic lymphoma (SLL) in November 2022.
“Our ambition is to develop treatments that can provide meaningful time to patients and ultimately that can lead to cure. Treating cancer early is one of the critical ways of making this happen,” said AstraZeneca SVP of Late Development Oncology R&D, Cristian Massacesi on the panel discussion.
To these ends, AstraZeneca is scoring well so far at ASCO.
