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2022-06-07| Special

ASCO 2022: AstraZeneca, Pfizer, Novartis Share Key Data on Breast Cancer Therapeutics

by Fujie Tham
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Photo by © ASCO/Todd Buchanan 2022

The American Society of Clinical Oncology’s (ASCO) annual meeting commenced on June 3rd saw drugmakers sharing their latest advancements in cancer immunotherapies. This year’s ASCO meeting was highlighted by AstraZeneca and Daiichi Sankyo Enhertu’s impressive data, Norvartis’ Kisqali, and Pfizer’s Ibrance.

 

AstraZeneca’s Enhertu Could Be the First HER2-Directed Cancer Medicine

 

Results of the Phase 3 DESTINY-Breast04 trial presented during ASCO 2022’s Plenary Session and simultaneously published in The New England Journal of Medicine, showed that Enhertu (trastuzumab deruxtecan) demonstrated superior parameters in patients with HER2-low unresectable/metastatic breast cancer with hormone receptor (HR) positive or HR-negative disease versus standard chemotherapy.

AstraZeneca and Daiichi Sankyo’s Enhertu halved risk of breast cancer progression compared to chemotherapy and reduced risk of death by 36% in patients with previously treated HER2-low metastatic breast cancer. Among all patients, the HER2-directed antibody drug conjugate (ADC) improved the median time patients had lived without disease progression to 9.9 months, versus 5.1 months for chemotherapy patients. With this landmark clinical trial success, AstraZeneca and Daiichi Sankyo could shift how breast cancer is diagnosed and categorized, instead of considering HER2 expression as “positive” or “negative”, but exactly how much is expressed, opening up treatments for patients who are somewhere in between. Chemotherapy is the typical treatment for many of these patients.

Shanu Modi, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center, US and Principal Investigator for the trial, who also presented the data said: “The results of DESTINY-Breast04 show for the first time that a HER2-directed therapy can provide a survival benefit to patients with low HER2 expression, indicating we must reconsider the way we categorize patients with metastatic breast cancer. The efficacy seen with Enhertu also reinforces the potential to establish a new standard of care for more than half of all patients with breast cancer currently categorized as having HER2-negative disease, but who actually have tumors with low HER2 expression.”

Related article: ​​FDA Grants AstraZeneca and Daiichi Sankyo’s Breast Cancer Drug Its Fifth Breakthrough Label

Progression-Free Survival and Overall Survival Results in HR-Positive and All Patient Populations from the DESTINY-Breast04 Trial
Progression-Free Survival and Overall Survival Results in HR-Positive and All Patient Populations from the DESTINY-Breast04 Trial.
Abbreviations: HR, hormone receptor; mOS, median overall survival; mPFS, median progression-free survival; T-DXd, trastuzumab deruxtecan; TPC, treatment of physician’s choice.

Pfizer’s Ibrance & Novartis’ Kisqali CDK4/6 Battle

 

As the first CDK4/6 inhibitor on the market, Pfizer’s Ibrance has maintained a huge market lead over later competitors such as Novartis’ Kisqali and Eli Lilly’s Verzenio. But according to data presented at ASCO 2022, Ibrance is the only CDK4/6 medication without a positive overall survival win in a Phase 3 trial, the drug did not improve the lifespan of new patients diagnosed with HR+, HER2- breast cancer in its PALOMA-2 trial.

The PALOMA-2 trial, after evaluating Ibrance in combination with Novartis’ Femara with a median follow-up of 90 months, found Pfizer’s drug failed to extend the lives of patients compared with Femara-only. Patients treated with Ibrance and Femara lived a median 53.9 months, compared to 51.2 months for the Femara-only group. 

“Interpretation of [overall survival] in PALOMA-2 is limited by the large and disproportionate censoring of patients with missing survival data between treatment arms,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “IBRANCE continues to provide substantial benefit as a first-line treatment for adults with HR+, HER2- mBC based on strong progression-free survival data, which formed the basis of its worldwide approvals.”

On the other hand, Norvatis’ Kisqali data tout it as the only drug in class with consistently proven overall survival benefit in HR+/HER2- metastatic breast cancer. 

In the latest Phase 3 MONALEESA-2 study update, Kisqali used with Femara maintained an overall survival benefit for patients with HR+/HER2- metastatic breast cancer treated in the first-line. Median survival seen in this trial was 66.0 months in patients with at least one Kisqali dose reduction from the 600mg starting dose compared to 60.6 months in patients who did not have a dose reduction. Additionally, survival benefit was observed in all patient subgroups treated with Kisqali and Femara.

The update scores Novartis another win against Pfizer, its MONALEESA-2, 3 and 7 trials all demonstrated survival improvements in breast cancer populations.

Related article: Recent Advances in Breast Cancer Treatments: An Overview

 

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