ASCO15 EXCLUSIVE: Merck & Co.’s Breast Cancer Drug Beats Chemo Rates and Will Roll Into Phase III, Says Investigator

Published: Jun 01, 2015

ASCO15 EXCLUSIVE: Merck’s Breast Cancer Drug Beats Chemo Rates and Will Roll Into Phase III, Says Investigator
June 1, 2015
By Riley McDermid, Breaking News Sr. Editor

A lead investigator on Merck & Co. ’s recent Phase II study of investigational cancer drug MK-2206 told BioSpace Monday that data presented at the American Society of Clinical Oncology (ASCO)’s annual meeting shows enough progress in treating breast cancer that it could be “pathway” to approval by U.S. regulators.

Dubbed the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2), the randomized Phase II clinical trial enrolled women with newly diagnosed Stage 2 or 3 breast cancer.

The trial found that MK-2206 improves pCR rates compared to standard chemotherapy in several breast cancer signatures, defined mostly by HR- and HER2+. Those results were good enough to roll the drug into a Phase III neoadjuvant trial powered for event-free survival, Merck said.

One of the lead investigators, Debu Tripathy, professor and chair for the Department of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center, told BioSpace the trial’s methodology was designed to figure out what treatments will work best for breast cancer patients across the board.

“The I-SPY 2 program aims to accelerate the discovery of drugs that are likely to be effective in breast cancer through an adaptively designed randomized trial in patients undergoing preoperative chemotherapy for breast cancer at high risk for recurrences,” Tripathy told BioSpace.

The trial attempted to answer whether adding biologically targeted investigational drugs to standard chemotherapy in the neoadjuvant (pre-operative) setting is better than standard chemotherapy—particularly for patients who have a high risk of relapse using up-front tumor profiling (including tumor size, hormone receptor status (HR), HER2 status, and the MammaPrint 70-gene signature test).

The data presented as ASCO can be parsed via the table below. They showed MK-2206 graduated in the first three signatures in the table. Accrual ended with 93 patients assigned to that arm and when 56 pts had been concurrently randomized to control. Final posterior and predictive probabilities are shown for all 10 signatures.

“This trial provides real-time analysis of the ability of the test drug to improve the pathological complete response rate when added to standard chemotherapy specific biomarker signature groups based on hormone and HER2 receptor and gene expression profiling scores,” said Tripathy.

“This endpoint has been shown to be associated with improved disease-free and overall survival,” Tripathy told BioSpace. “The threshold for a drug’s successful ‘graduation’ is based on a 85 percent or greater probability of success with specific signatures in a larger neoadjuvant trial that is of the size that could be a pathway to FDA approval.”

The I-SPY 2 TRIAL involved academic investigators from 20 major cancer research centers across the U.S., as well as public and private sector backers like the Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium, The Safeway Foundation and the Bill Bowes Foundation.

ASCO15 EXCLUSIVE: Merck & Co.’s Breast Cancer Drug Beats Chemo Rates and Will Roll Into Phase III, Says Investigator

Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”

Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.

“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”

We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?

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