AstraZeneca releases positive results for breast cancer treatment

AstraZeneca presented positive results from its Phase III OlympiAD trial on Monday, which showed a “statistically significant” and “clinically meaningful” improvement in progression-free survival for BRCA-mutated metastatic breast cancer patients treated with Lynparza (olaparib) tablets - 300mg twice daily - compared to treatment with physician's choice of a standard of care chemotherapy.

The FTSE 100 drugmaker said that in addition to meeting its primary endpoint of progression-free survival assessed by blinded independent central review, the trial showed that patients treated with Lynparza had a 42% reduction in the risk of their disease worsening or death compared to those who received chemotherapy.

In a statement, the company described OlympiAD as a “randomised, open label, multi-centre” Phase III trial assessing the efficacy and safety of Lynparza to “physician's choice” chemotherapy - capecitabine, vinorelbine, eribulin - in 302 patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to be deleterious.

AstraZeneca said the international trial was conducted in 19 countries from across Europe, Asia, North America and South America.

The data was being presented at the 2017 ASCO Annual Meeting in Chicago, during Monday's Plenary Session.

It said the trial was designated for the ‘Best of ASCO’ selection, which the board said underscored the importance of the results for patients and physicians, with the results published in the New England Journal of Medicine.

“The OlympiAD data presented today demonstrate the benefit of olaparib in delaying the progression of advanced BRCA-mutated breast cancer,” said Mark Robson, principal investigator of Olympiad and the clinic director of the clinical genetics service at Memorial Sloan Kettering Cancer Center in New York.

“With few alternatives available, a targeted non-chemotherapy oral treatment in this setting could be a beneficial new option for patients.”

Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said the OlympiAD results marked the first time a targeted therapy showed benefit over the current standard of care for patients with HER2-negative gBRCA-mutated metastatic breast cancer.

“This also represents an important milestone for Lynparza as this is the first positive Phase III trial in which a PARP inhibitor has shown a significant benefit for patients outside of ovarian cancer.”

Patients in the trial had HER2-negative germline BRCA1 or BRCA2-mutated breast cancer and were receiving Lynparza as their first, second or third-line medicine for metastatic disease.

Before enrolment, patients had prior treatment with an anthracycline - unless contraindicated - and a taxane.

Hormone receptor-positive patients received at least one endocrine medicine or were not eligible for endocrine medicines.

Secondary endpoints showed an improvement in time until second progression or death in the Lynparza arm of the trial, compared to those treated with chemotherapy, AstraZeneca claimed.

In addition, the objective response rate was more than doubled, with 59.9% of patients in the Lynparza arm showing response to treatment, compared to 28.8% of patients treated with chemotherapy.

A review of the Lynparza safety data from the OlympiAD trial did not identify any new safety signals and the overall safety profile was consistent with previous trials of Lynparza.

There was a lower incidence of grade ≥3 adverse events in the Lynparza arm compared to the chemotherapy arm, at 36.6% vs 50.5% respectively.

The company said a smaller proportion of patients discontinued treatment in the Lynparza arm compared to the chemotherapy arm, at 4.9% vs 7.7% respectively.