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GSK, BioMerieux to Develop, Globally Launch Predictive Breast Cancer Dx to Guide Treatment

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By Turna Ray

GlaxoSmithKline and French diagnostics firm BioMerieux are collaborating on the development of a predictive genetic test to guide breast cancer treatment, the partners announced this week.

"This test, based on emerging biomarkers, will be intended for use in both adjuvant and metastatic breast cancer settings [and] subject to regulatory approvals," BioMerieux said in a statement.

Both GSK and BioMerieux will shoulder the cost for the test's development. Additional financial details were not disclosed.

GSK will conduct the clinical trials and provide patient samples from several clinical trials. The diagnostic will be developed by BioMerieux subsidiary BioTheranostics, which operates a CLIA laboratory in the US.

Initially, the predictive breast cancer diagnostic BioMerieux is developing will be launched as a homebrew test. The company will then develop an in vitro diagnostic kit and submit it for regulatory approval.

Companion Drugs for the Dx?

GSK did not reveal the specific breast cancer drugs in its portfolio or pipeline that the predictive test would accompany. However, the news of this Rx/Dx partnership follows the UK National Institute for Health Clinical Excellence's refusal to pay for GSK's Tykerb (lapatinib) as a first-line treatment for HER2-positive breast cancer, finding it was not cost-effective.

GSK had offered to provide lapatinib to UK's breast cancer patients for free for the first three months, but the National Health Service wasn't swayed by the offer. The company estimates that NICE's refusal to pay for lapatinib restricts access to approximately 2,000 British breast cancer patients.

In the UK, drugmakers have been able to eventually launch treatments initially refused coverage by NICE by figuring out who the best responders are in genetically defined subpopulations. This was the experience that Amgen and Merck/ImClone had with Vectibix and Erbitux, respectively [see PGx Reporter 07-22-2009].

European regulators' recommendation for genetic testing prior to administering these colorectal cancer drugs was also echoed by the FDA.

In April, GSK submitted an application to the FDA for Tykerb's approval as a first-line treatment for women with advanced, hormone-sensitive breast cancer. The drug is currently approved in the US as a treatment for HER2-positive breast cancer, in combination with Xeloda, following treatment with an anthracycline, a taxane, and Herceptin.

Other than in first-line treatment, GSK is studying Tykerb as a single agent in refractory, inflammatory breast cancer (Phase II) and as adjuvant therapy for breast cancer (Phase III). The company is also looking at Tykerb in combination with pazopanib, an investigational multi-kinase angiogenesis inhibitor, in inflammatory breast cancer (Phase III) and in metastatic breast cancer (Phase II).

Tykerb is marketed in 27 European Union countries and other nations.

Global Networks

BioMerieux and GSK are ultimately planning to launch the predictive breast cancer test on a global scale, "leveraging resources of BioMerieux and the collaboration." In this regard, BioMerieux's capacity to scale up the development and marketing of the test likely played a big part in GSK's decision to work with the diagnostics developer.

BioMerieux's theranostics strategy focuses on infectious diseases and cancer. The BioTheranostics team has previously developed the Theros CancerType ID test for identifying metastatic cancers of uncertain or unknown origin, as well as the Theros Breast Cancer Index test for predicting breast cancer recurrence risk.

GSK's previous Rx/Dx deals suggest that the drug developer prefers to work with larger diagnostics firms who have access to global networks to facilitate the simultaneous introduction of the drug and diagnostic product.

In July, Abbott Molecular Diagnostics penned a deal with GSK to develop a PCR-based molecular diagnostic test, based on Abbott's m2000 instrument platform, which will screen NSCLC tumors for expression of the MAGE-A3 antigen, in order to determine which patients should receive GSK's MAGE-A3 Antigen Specific Cancer Immunotherapy [see PGx Reporter 07-15-2009].

Although GSK worked with a smaller diagnostics shop, Response Genetics, to genetically screen patients in clinical trials for MAGE-A3 ASCI, that relationship did not extend to the commercial development of a companion diagnostic. Discussing its collaboration with GSK, a company spokesperson suggested to Pharmacogenomics Reporter at the time that in seeking a commercial diagnostic partner for MAGE-A3 ASCI, GSK was looking for a larger shop with more commercial scale-up capabilities and regulatory experience.

This emerging trend of big pharma working with larger diagnostics shops continued with Pfizer also picking Abbott Molecular Diagnostics to develop a companion test for its investigational lung cancer drug known as PF-02341066 [see PGx Reporter 09-02-2009].

BioMerieux is a global diagnostics developer, operating in 150 countries through 39 subsidiaries, and a "large network of distributors."

Its high-complexity CLIA lab, combined with BioMerieux's global IVD business, "supports aggressive development timelines while ensuring test availability wherever the drug is sold," the company highlighted in a statement.

In 2008, BioMerieux netted revenues of €1.1 billion ($1.6 billion) with 84 percent of sales outside of France, the company said.

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