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Genomic Health Updates Analysts on Companion Dx Pipeline, New Education Campaign

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By Turna Ray

Updating analysts on its ongoing work with drug companies during a conference call this week, Genomic Health said it may develop a companion test for Bristol-Myers Squibb/Imclone/Lilly's colorectal cancer drug Erbitux that gauges markers in addition to KRAS.

Genomic Health said it is also writing up a study on a companion test it is developing for Pfizer's renal cancer drug Sutent.

Genomic Health officials discussed the ongoing drug/diagnostic codevelopment work during a call to discuss the company's financial results for the third quarter, in which it posted a 17 percent increase in revenues to $39.5 million from $46.3 million in the third quarter of 2009.

The company also recorded net income of $3.7 million for the three months ended Sept. 30, compared to a net loss of $502,000 for the third quarter last year.

Kim Popovits, president and CEO of Genomic Health, attributed the company's second consecutive profitable quarter to increased worldwide sales of Oncotype DX breast and colon cancer tests and to increasing reimbursement worldwide.

The company said it delivered more than 14,700 Oncotype DX test results during the third quarter, an increase of 17 percent year over year. In total, its product revenues grew 18 percent to $45.8 million from $38.9 million in the third quarter of 2009.

Product revenue was bolstered by the company's growing international presence. According to Genomic Health, international sales of Oncotype DX breast and colon cancer tests now represent more than 10 percent of overall product revenues.

During the quarter, Genomic Health signed contracts for payment for the Oncotype DX breast cancer recurrence test with hospitals in the UK, Ireland, and Mexico; and a payor in Greece. Additionally, the company secured reimbursement for its Oncotype Dx colon cancer test from insurers in Greece covering more than 20 percent of the population for stage II colon cancer.

In the US, Genomic Health established contracts with the Blue Cross Blue Shield plans of Delaware, Florida, and Montana, and with Blue Cross of Northeastern Pennsylvania, for estrogen-receptor positive node-negative breast cancer, including patients with micrometastases. Additionally, the company inked a contract with EmblemHealth providing in-network benefit coverage for approximately 3.3 million lives in the Northeast for certain estrogen-receptor positive breast cancer patients.

Genomic Health's third-quarter R&D spending was $8.2 million, down 10 percent from $9.1 million for the third quarter of 2009, while its SG&A expenses increased around 15 percent to $25.9 million from $22.6 million.

During the quarter, the Eastern Cooperative Oncology Group finished enrolling more than 10,000 early-stage breast cancer patients in the Trial Assigning Individualized Options for Treatment, or TAILORx, clinical trial. The trial aims to find out whether gene expression testing with Oncotype DX can be used to effectively guide treatments for women at risk of breast cancer recurrence. The NCI-funded project is slated for completion in 2015.

Additionally, the company said it will present new data in December on studies related to a prostate cancer test it is developing; is conducting a large clinical trial in ductal carcinoma in situ; and completed sample processing for a second recurrence study in stage II colon cancer.

Popovits also discussed the launch of a new online patient information campaign that informs breast cancer patients and their families about how they can personalize their treatment decisions with the help of Oncotype DX.

Separately, the National Comprehensive Cancer Network issued its first breast cancer treatment guidelines for patient use, in which it recommended Oncotype DX as a diagnostic tool "because it has been tested and determined to be able to predict which women can safely undergo chemotherapy."

Genomic Health finished the quarter with $23.6 million in cash and cash equivalents and $46.1 million in short-term investments.

Companion DX Potential

As Genomic Health looks to further penetrate the companion diagnostics space, the company is seriously considering developing a test to administer Erbitux (cetuximab) to colorectal cancer patients most likely to respond. "We certainly think it's possible in the future that it makes sense for us to develop a test that addresses resistance to cetuximab," Joffre Baker, Genomic Health's chief medical officer, told analysts during the call.

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Two years ago, researchers from Genomic Health, BMS, and Imclone analyzed formalin-fixed paraffin-embedded primary tumors from 226 metastatic colorectal cancer patients on Erbitux. In the study, presented at the 2008 American Society of Clinical Oncology's annual meeting, researchers attempted to discover and validate markers linked to disease control and improved progression-free survival in cetuximab-treated patients by retrospectively measuring KRAS sequences (seven mutations and one wild-type) and gauging the expression of 102 candidate genes by quantitative RT-PCR.

Researchers in that study reported that among all 226 patients, quantitative expression of 40 genes was "significantly associated with disease control (p

"Genes that were strongly associated with disease control in both analyses included genes encoding the EGFR ligands epiregulin (EREG) and amphiregulin (AREG)," the authors reported. "Based on these results, we have developed multi-gene predictors that incorporate EREG and AREG, which when used in conjunction with KRAS mutation status increase the ability to predict who might benefit from cetuximab treatment over KRAS mutation status alone."

Referring to this study, Baker said during the earnings call this week that the company remains "very excited" about those early results. He added that "disappointing" findings presented at ASCO this year by researchers from the Mayo Clinic and elsewhere further highlight the need for researchers to "go beyond KRAS mutations" to guide treatment with Erbitux.

In the Mayo Clinic study, Steve Alberts and colleagues investigated the efficacy of Erbitux in combination with mFOLFOX6 (modified infusional 5-fluorouracil, leucovorin, and oxaliplatin) in metastatic colorectal cancer patients with wild-type KRAS tumors. "In this randomized phase III trial the addition of cetuximab to mFOLFOX6 was of no benefit for patients with resected stage III wild-type KRAS colorectal cancer," the researchers concluded. This study was funded by an NIH grant, BMS, Imclone, Sanofi-Aventis, and Pfizer.

Genomic Health Chief Medical Officer Steve Shak agreed that results from the Alberts et al. study were a disappointment in terms of the utility of KRAS mutation testing in colorectal cancer patients. "We wanted to highlight that also in this setting we need to do more research to better understand the right patients to treat, and going beyond KRAS probably makes sense," he told PGx Reporter.

"We did those early studies to figure out whether it was even feasible" to advance to developing a commercial predictive test, Shak said. "We're still talking with [Erbitux's sponsors] in terms of the next studies and the next steps." Shak could not elaborate on what those next steps might be at this point.

Pharmacogenetic tests that gauge markers in addition to KRAS and can further hone in on the best responders to EGFR-inhibiting monoclonal antibodies such as Erbitux stand to be a fast-growing, highly-competitive enterprise.

Earlier this year, Merck KGaA, Almac Diagnostics, and UK's Medical Research Council said they would conduct a clinical trial to identify biomarkers other than KRAS mutations that can be used to gauge treatment benefit from the addition of Erbitux to chemotherapy (PGx Reporter 04/21/10). Merck KGaA markets Erbitux outside the US and Canada.

Separately, Amgen, maker of Vectibix (panitumumab), a drug that competes with Erbitux as a treatment for metastatic colorectal cancer, presented data at ASCO from a trial in which the sponsor used next-generation sequencing to investigate whether mutations in nine genes "beyond KRAS" predict response to Vectibix. The study, which sequenced samples collected as part of a previously conducted Phase III study, reported that in addition to KRAS, NRAS mutations may be predictive of Vectibix response.

If Genomic Health were to develop a PGx test for Erbitux, the company would certainly be competing with Qiagen.

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Both BMS and Amgen are working with Qiagen subsidiary DxS to market companion diagnostics to gauge KRAS mutations. Stephen Little, Qiagen's vice president for personalized healthcare, previously told PGx Reporter that the company has every intention of expanding its panel of markers that gauge response to EGFR-inhibiting colorectal cancer drugs, but only when additional markers are sufficiently validated and found to be clinically useful.

Genomic Health is developing another companion test in collaboration with Pfizer. The test will be used to guide renal cancer treatment with Sutent and is slated for launch in 2013.

Shak said during the earnings call that the company is working to write up a study conducted in support of this test for publication.

"That work highlighted that the biology matters in renal carcinoma. It turned out to be a different biology than the biology we saw in colon cancer and breast cancer," Shak said. "And we still have ongoing discussions with Pfizer in terms of the next steps. We'll report that when we have something more definitive to say."

Shak told PGx Reporter after the earnings call that the companion test will still be based on the real-time PCR-based Oncotype DX gene expression platform, but will gauge a different set of genes than the company's breast and colon cancer recurrence tests.

Getting the Word Out

During the call, Popovits discussed the launch of a new online tool and campaign, dubbed "Until Every Woman Knows," that aims to educate women with breast cancer and their families about how to make personalized treatment decisions.

The website uses "video sharing tools and social media to spread information to patients and their personal networks," Popovits said. "It is our goal that every woman touched by breast cancer, whether by their own diagnosis or by someone they know, be empowered to ask their doctor if Oncotype DX is right for them."

Genomic Health has previously estimated that its flagship Oncotype DX breast cancer recurrence test has penetrated around 30 percent of the US breast cancer market. However, company officials believe that they can grow the test's market share, particularly among node-negative patients, beyond 50 percent and closer to 80 percent of the market.

Through campaigns such as "Until Every Woman Knows," Genomic Health is certainly hoping to further penetrate the Oncotype DX breast cancer market.

According to Popovits, during the first month of the campaign, the site was visited by 100,000 people. "We are encouraged by this initial response and believe this program, in conjunction with other patient education resources developed by Genomic Health, will help us reach all eligible breast cancer patients who can benefit from the recurrence score and treatment planning," she added.

Before launching the current campaign, Genomic Health developed with breastcancer.org a website called My Breast Cancer Treatment Coach, which provides personalized treatment guides and suggests questions that newly diagnosed breast cancer patients should ask their doctors. The company also sponsors another website, mytreatmentdecisions.com, that provides patient treatment decision support and features patients' experiences with Oncotype DX.


Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at tray [at] genomeweb [.] com
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