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MDx/CDx Focus: Siemens Inks Companion Dx Partnerships; FDA Accepts Roche's Pertuzumab BLA

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Siemens Inks New Companion Dx Collaborations with ViiV Healthcare, Tocagen

Siemens Healthcare Diagnostics this week announced that it is developing an HIV genotyping test that ViiV Healthcare is using in a clinical trial involving its HIV tropism drug Selzentry.

ViiV Healthcare is currently recruiting patients for a Phase III study, called MODERN, comparing Selzetnry and Gilead's Truvada (emtricitabine/tenofovir), when both are administered in combination with a darunavir/ritonavir regimen. The aim of the 96-week study is to investigate if Selzentry plus darunavir/ritonavir is inferior to Truvada when combined with the same drugs. Researchers aim to enroll more than 800 HIV patients who are antiretroviral naïve.

The study will also compare the ability of Monogram Biosciences's Trofile tropism test and a genotyping test developed by Siemens to determine which patients should receive Selzentry. "Patients will be randomized to undergo screening with either the genotypic or [Monogram's] phenotypic test," Siemens said in a statement.

"Subject to US Food and Drug Administration approval, Siemens Healthcare Diagnostics may commercialize their genotypic tropism diagnostic test," the company said in a statement.

As previously reported by PGx Reporter sister publication Clinical Sequencing News, Siemens is developing an HIV assay on Illumina's MiSeq personal sequencing platform. Illumina CEO Jay Flatley has said that this next-generation sequencing-based HIV test "may be the first" diagnostic to be submitted for regulatory approval on the MiSeq platform (CSN 12/7/2011).

Ahead of administering Selzentry, physicians are required by the drug's label to establish the tropism status of a patient's HIV by "a highly sensitive tropism assay." In developing the drug, Pfizer inked a non-exclusive agreement with Monogram, a subsidiary of the Laboratory Corporation of America, to market and distribute globally its tropism test Trofile (PGx Reporter 12/6/2006). In 2009, Pfizer shifted commercial activities related to Selzentry over to ViiV Healthcare, a new spin-off venture between Pfizer and GlaxoSmithKline to market the two firms' HIV treatments.

In addition to its work with ViiV to develop an HIV tropism companion test, Siemens this week announced a partnership with Tocagen to advance diagnostic tests to support clinical trials for Tocagen's viral gene therapies Toca 511 and Toca FC for the treatment of primary brain cancer. Under this partnership, Siemens said it may also commercialize diagnostic for therapy monitoring, if these tests garner regulatory approval.

"Complementing a move into next-generation sequencing, Siemens' companion diagnostics business will establish relationships with pharmaceutical companies to offer clinical trial expertise as well as diagnostic test development and commercialization," Siemens said in a statement. The company runs a CLIA-certified clinical lab in Berkeley, Calif.


Roche's Investigational HER2-Positive Breast Cancer Drug Gets FDA Priority Review

The US Food and Drug Administration will conduct a priority review of Roche's biologics license application for pertuzumab, the company announced this week.

Under the priority review scheme, FDA is slated to take action on the application by June 8. Roche is seeking approval for pertuzumab in combination with Herceptin and docetaxel chemotherapy as a treatment for HER2-positive metastatic or locally recurrent breast cancer when the tumor cannot be removed by surgery, when patients haven't received prior treatment, or in those patients whose cancer relapses following adjuvant chemotherapy.

Pertuzumab hinders the HER2 receptor from pairing or dimerizing with other HER receptors, such as HER1, HER3 and HER4. In this way, the drug has been shown in clinical trials to block cell signaling, which in turn can kill cancer cells or stop their growth.

As part of the BLA, Roche submitted data from the Phase III CLEOPATRA study, which found that patients treated with the pertuzumab/Herceptin/docetaxel regimen were alive six months longer without their disease progressing, compared to women who were treated with Hercpetin and docetaxel. People who received the investigational agent also had a 38 percent reduction in the risk of their disease worsening or death.

Roche subsidiary Genentech and cancer diagnostics company Dako have said they will work together to garner FDA clearance for two HER2 companion diagnostics for the pertuzumab regimen. Dako plans to file regulatory applications for HercepTest and Her2 FISH pharmDx.

-- TR

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