Medical Device Link.

Abbott’s molecular diagnostics unit (Des Plaines, IL) is working with pharmaceutical giant Pfizer on developing a molecular diagnostic test to screen non-small-cell lung cancer (NSCLC) tumors for the presence of gene rearrangements. Pfizer has created an investigational therapy, known as PF-02341066, which selectively targets cancer-causing genes implicated in the progress of the cancer in individuals harboring a particular gene rearrangement. Abbott is responsible for developing the lung cancer tissue test for that genetic rearrangement. About 6-7% of non-small-cell lung cancer patients have the rearrangement and thus would be candidates for clinical trials of PF-02341066.

Donald Braakman, director, public affairs, for Abbott’s diagnostics businesses, says the collaboration was Pfizer’s idea. “Generally, the awareness of Abbott’s expertise in molecular diagnostics and in the broad technology program that we have available has increased considerably over the last couple of years,” he says. Abbott has participated in a number of these types of collaborations with pharmaceutical companies this year and last, he adds.

Abbott draws on two key technologies when it develops companion diagnostic tests: polymerase chain reaction (PCR) for DNA amplification and fluorescence in situ hybridization (FISH) for examining gene copies in a cell. Abbott’s companion diagnostic test for the breast cancer drug Herceptin is an example of a test that is based on PCR and FISH. Braakman cites the Herceptin test, which is included in Herceptin’s labeling, as being an example of a successful companion diagnostic: “That model is ideally where we would like to go with a lot of these collaborations, where the drug and the diagnostic test would actually be in the labeling, so it’s clear to the physicians how to use the diagnostic test.”

As of this writing, a Phase 3 randomized, open-label study of the antitumor activity and safety of PF-02341066 is “open and enrolling in the United States, and will be enrolling globally by the end of this year,” according to a Pfizer press release. The trial is expected to enroll 318 patients. Braakman says that the ultimate goal is for the drug and the diagnostic test for patient selection to “go hand in hand in treating the patient,” in the same way that the Herceptin drug and diagnostic test do.

“There has been a lot of discussion of personalized medicine over the past ten years,” Braakman says. “I think a collaboration like this one is indicative of the real-world applications for companion diagnostics and therapeutics. That’s really where personalized medicine is going: the right therapeutic for the right patient. The benefits to the patient are immeasurable.”

Braakman says that more than 500,000 cases of NSCLC are diagnosed globally each year. “It’s a fairly common and aggressive cancer,” he says.

Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s oncology business unit, is quoted in a company press release as saying that Pfizer views its work on PF-02341066 and collaboration with Abbott as an “extraordinary opportunity for rational drug development.” This work “represents a shift from large trials designed to detect a small benefit in a large group of patients toward looking for a bigger effect in a smaller, better characterized group of patients,” he says.

As for the potential for companion diagnostics and therapeutics to reduce healthcare costs overall, Braakman says “that’s certainly the hope for the future, going forward.” He emphasizes that the focus now, however, is on improved patient care.

Last July, Abbott embarked on a similar collaboration with GlaxoSmithKline (GSK). GSK asked Abbott to develop a commercial test to accompany its investigational NSCLC immunotherapeutic, after discussions with FDA reportedly determined that a companion diagnostic would be required for marketing approval of the drug. GSK and Abbott announced in July a deal to develop a PCR-based test to screen NSCLC tumors for expression of the MAGE-A3 antigen to determine which patients should receive GSK’s antigen-specific cancer immunotherapy product.