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Pfizer, Abbott Ink Deal to Develop Companion Dx for PGx-based NSCLC Drug


By Turna Ray

Abbott Molecular Diagnostics announced last week it is developing a genetic test that will determine which non-small cell lung cancer patients should receive Pfizer's investigational drug known as PF-02341066. The deal is the second announced by Abbott in the last two months to develop a pharmacogenomic-based companion diagnostic for a NSCLC drug with a major drugmaker.

At the American Society of Clinical Oncology's annual meeting earlier this year, Pfizer announced results from a Phase I study in which PF-02341066 — a dual inhibitor of mesenchymal epithelial transition growth factor (c-met) and anaplastic lymphoma kinase translocation genes — caused tumor shrinkage in 10 out of 19 patients for between two and 23 weeks. The drug also stopped tumor growth in five patients for between eight weeks and 40 weeks [see PGx Reporter 06-03-2009].

"To be eligible to receive Pfizer's oral therapy, a particular genetic translocation (rearrangement) known to be found in NSCLC tumors and a wide variety of other cancers, but not in normal cells, must be present," Abbott said in a statement, adding that under terms of the agreement, it will develop a companion diagnostic test "that will determine a patient's genetic status and will be used in patient selection for future clinical trials of PF-02341066."

Pfizer has previously touted PF-02341066 as "the first agent in clinical development that selectively targets a unique genetic feature of cancer cells." The drug is currently in Phase III trials, while Abbott is in the process of designing validating trials for a companion test with the capability to detect ALK gene rearrangements, according to a company spokesperson.

Abbott would not disclose the financial details of its collaboration with Pfizer. Nor would the spokesperson describe the technology platform for the companion test or discuss its regulatory strategy for submitting the companion test to the US Food and Drug Administration.

"Abbott Molecular has broad capabilities — and multiple technologies — for developing novel genetics-based tests to determine patients' gene status," the Abbott spokesperson told Pharmacogenomics Reporter without elaborating. "We have not disclosed the specific clinical milestones yet."

In July, Abbott penned a deal with GlaxoSmithKline 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 it's 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.

Similarly, during lean economic times, Pfizer may have decided to work with Abbott, searching for a diagnostics partner that would require less investment than a smaller company. Historically, Pfizer has worked with comparatively smaller diagnostic shops, such as Monogram Biosciences and Genomic Health to develop tests for its pharmacogenomically guided drugs. In doing so, Pfizer has made significant investments in the companies, shouldering the brunt of the development and marketing costs.

For instance, in using Monogram to develop the companion diagnostic tests for the HIV drug Selzentry, Pfizer took over global distribution for the test and invested $25 million in the diagnostics company [see PGx Reporter 05-10-2006]. Monogram has since been acquired by Laboratory Corporation of America in a deal that closed Aug. 4.

Although the financial details were not announced for Pfizer's collaboration with Genomic Health to develop a test for patients with Stage I-III, localized, clear cell-type renal carcinoma, collaborating with a pharmaceutical behemoth like Pfizer will undoubtedly benefit Genomic Health when it comes time to market the test and negotiate with payors [see PGx Reporter 01-09-2008].

Pfizer was not able to respond to questions about its collaboration with Abbott ahead of publication.

Specifically, PF-02341066 targets echinoderm microtubule-associated protein-like 4 (EML4)-ALK translocation, which is present in some NSCLC patients. The abstract for the study presented at the ASCO meeting, by Kwak et al., is available here.

During ASCO's annual meeting researchers from the Massachusetts General Hospital Cancer Center and other institutions noted that although PF-02341066 yielded promising results in early studies in NSCLC patients carrying activating ALK gene rearrangements, further study of the drug in patients with ALK-dependent tumors is needed.