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MDx/CDx Focus: Studies Reported At ESMO on Roche's Herceptin, T-DM1, Pfizer's Xalkori

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Roche, BIG Report Data Showing One or Two Years of Herceptin Doesn't Change Survival

At the Congress of the European Society for Medical Oncology in Vienna this week, Roche and the Breast International Group today reported data from the Phase III HERA trial showing that two years of treatment with Herceptin does not significantly extend the time women live without their disease returning compared to those treated with the drug for one year.

Final results from the HERA trial "confirmed that one year of Herceptin treatment remains the standard of care for people with early-stage HER2-positive breast cancer," Roche said in a statement. There was no difference in overall survival between these two arms, though there was a 24 percent reduction in the risk of death between patients receiving Herceptin for one year versus being followed by observation alone.

The Phase III, open-label trial, involved more than 5,000 women randomized to receive one year of Herceptin, two years of the drug, or followed by observation only after surgery, which was the standard of care when HERA was launched. Patients in the study had been previously treated with chemotherapy or radiotherapy post breast cancer surgery, and women whose breast cancer had spread to the lymph nodes, as well as lymph node negative patients, were enrolled.

The primary study endpoint was disease-free survival comparing patients receiving Herceptin for one year to those in the observation arm, and disease-free survival comparing those receiving the drug for one year versus two years. Other endpoints were overall survival, relapse-free survival, and distant disease-free survival.

Although no new safety issues were observed in the trial, the researchers found that patients treated with Herceptin for two years experienced "a slightly higher incidence of certain adverse events," compared to those treated for one year or followed by observation alone. For example, the heart's ability to pump blood out of the left ventricle was reduced in 7.2 percent, 4.1 percent, and 0.9 percent of patients in the two-year, one-year Herceptin treatment, and observation arms, respectively.

Herceptin is approved in the US as a treatment for metastatic breast and early-stage breast cancer patients whose tumors overexpress the HER2 protein. Regulatory authorities and international treatment guidelines support one year of Herceptin treatment. If HERA had shown patient outcomes were significantly improved after two years of treatment, it could have changed standard practice and would have translated into additional revenue for Roche.

"It's essential that our clinical trials help us understand just how long patients need to receive a particular treatment,” said Martine Piccart, chair of BIG. “These results give us both the evidence and the reassurance that it’s not necessary to give patients with early-stage HER2-positive breast cancer Herceptin for more than one year."

Separately, the French National Cancer Institute has conducted a randomized, non-inferiority study comparing the impact of Herceptin on patients receiving the drug for six months versus for a year. This trial, called Phare, involves more than 3,000 patients and tracked disease-free survival in patients. Data from Phare suggests that six months of the drug is not significantly inferior to a year of the drug, but there is a trend favoring patients treated with Herceptin for a year. Further data on this study will be presented in December.


Pfizer Reports Phase III Data on Xalkori

Results from a Phase III trials showed the Pfizer's Xalkori (crizotinib) compared to standard chemotherapies (pemetrexed or docetaxel) has a greater impact on progression-free survival and response rates in non-small cell lung cancer patients harboring ALK mutations.

The US Food and Drug Administration approved Xalkori on an accelerated timeframe based on data from two early-stage trails. Pfizer conducted this Phase III trial as part of its post-marketing commitments. Pfizer reported the latest results at the Congress of the European Society for Medical Oncology in Vienna this week.

The Phase III randomized study compared the efficacy and safety of Xalkori against pemetrexed or docetaxel in 347 ALK-mutation positive NSCLC patients who had been previously treated with chemotherapy. In the study, patients receiving Xalkori experienced progression-free survival of 7.7 months compared to 3 months for patients treated with standard chemotherapy. Around 65 percent of Xalkori-treated patients responded to the drug while 20 percent responded to treatment on the chemo arm.

The overall survival data from this study is not yet mature. Patients on the chemotherapy arm were switched to receive Xalkori. Certain adverse reactions were more frequent for patients receiving Xalkori, but patients on this drug also reported improved quality of life.


Roche Reports Updated Data for T-DM1

Roche reported updated survival data from EMILIA, a multi-center, randomized, Phase III trial comparing the investigational agent trastuzumab emtansine against GlaxoSmithKline's Tykerb (lapatinib) plus Xeloda in HER2-positive advanced breast cancer patients.

EMILIA involved more than 900 women with HER2-overexpressing locally advanced or metastatic breast cancer who had previously received Herceptin and a taxane chemotherapy. In the trial, the risk of death was reduced by 32 percent for women receiving trastuzumab emtansine compared to those treated with the Tykerb/Xeloda treatment. T-DM1-treated patients experienced median overall survival of 30.9 months compared to 25.1 months for those in the comparator arm.

Researchers reported the data at the Congress of the European Society for Medical Oncology in Vienna this week.

Progression-free survival was a median of 9.6 months for women in the T-DM1 arm and 6.4 months for those on the Tykerb/Xeloda regimen. EMILIA data on progression-free survival was reported at the American Society for Clinical Oncology's annual meeting this summer (PGx Reporter 6/6/2012).

The researchers found no new safety signals. As previously reported, fewer people on T-DM1 experienced Grade 3 or higher adverse events than those on Tykerb/Xeloda.

Based on results from EMILIA, patients in the Tykerb/Xeloda arm are being switched over to receive T-DM1. Roche subsidiary Genentech plans to file for regulatory approval for T-DM1 with the US Food and Drug Administration this year.

HER2 overexpression is a prognostic marker for cancer and a predictive marker for drugs that target the receptor, such as Herceptin, a monoclonal antibody developed by Genentech that was approved by the FDA in 1998.

T-DM1 joins Herceptin with the chemotherapy DM1 via a stable linker. The two bonded agents attach to HER2-positive cancer cells, block abnormal signaling pathways driving tumor growth, and induce the body's immune system to destroy malignant cells.

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