Roche reported that Herceptin (trastuzumab) decreased the risk of death in patients with HER2-positive advanced stomach cancer by 26 percent, compared to chemotherapy alone, according to findings from a Phase III study. The additional details, presented at ASCO, follow the company’s announcement earlier this year that the trial had met its primary endpoint of improving overall survival. ASCO’s president, Richard Schilsky, remarked that the data will change medical practice and “will force us to test patients for HER2, treat patients who are HER2-positive, and conduct research on gastric cancer that is HER2-positive.”

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The randomised ToGA study enrolled 594 patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive gastric cancer, who received first-line treatment with either Herceptin plus chemotherapy, or chemotherapy alone. Data showed that patients in the Herceptin arm had a median overall survival time of 13.8 months, compared to 11.1 months for those in the chemotherapy-only group. Furthermore, Roche stated that patients with tumours exhibiting high levels of HER2 lived 16 months on average when Herceptin was added to treatment with chemotherapy.

Principal investigator Eric Van Cutsem commented that “this is the first Phase III study to report improved overall survival with a personalised, targeted treatment for gastric cancer” and “the first time a biological [drug] has improved survival in gastrointestinal cancer.” He also noted that Herceptin reduced the size of tumours and increased survival significantly beyond the one-year mark that has been a hurdle for patients with advanced gastrointestinal tumours.

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Corinne Wolter remarked that the drugmaker will file Herceptin, which is currently approved for the treatment of breast cancer, for regulatory approval in the stomach cancer indication in countries outside the US. Spokesperson Kristina Becker of Genentech said a decision to file for expanded approval with the FDA is under review. Nomura analyst Amit Roy estimated that approval of Herceptin in patients with HER2-positive stomach cancer could add $450 million to the product’s annual worldwide sales, which exceeded $4.7 billion last year.

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Roche announced Phase III study results on Wednesday which demonstrated that the use of Herceptin (trastuzumab) in combination with standard chemotherapy significantly prolonged overall survival in patients with HER2-positive advanced gastric cancer, compared with chemotherapy alone. William Burns, head of Roche’s pharmaceutical division, remarked that “the ToGA study shows for the first time that Herceptin extends the lives of patients in a cancer other than breast cancer.”

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The trial enrolled 594 patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive gastric cancer. The patients were randomised to receive first-line treatment with Herceptin in combination with chemotherapy, or chemotherapy alone. The primary endpoint was overall survival, while secondary endpoints included progression-free survival and overall response rate, Roche noted.

The drugmaker stated that complete results will be presented at an upcoming medical conference.

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Roche announced Wednesday that an analysis of new data from the ongoing, late-stage HERA study found that women with HER2-positive early breast cancer taking Herceptin (trastuzumab) had a 25-percent reduction in risk of disease recurrence after four years follow-up, compared with patients who did not take the drug.

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The study, which enrolled more than 5000 women, compared one year of Herceptin treatment versus no treatment with the drug, with a median follow-up of four years after entry into the study. Results showed that roughly 79 percent of women given Herceptin remained cancer-free, which Roche said was a significant increase when compared with the 73 percent of women in the observation arm of the study whose disease did not recur. In addition, the data indicated that almost 90 percent of Herceptin-treated women were still alive after four years.

Lead investigator Martine Piccart stated that “HERA is the first of the four large Herceptin studies in early HER2-positive breast cancer to substantiate the long-term benefit derived from one year of treatment.” The latest findings from HERA were presented at the Primary Therapy in Early Breast Cancer conference. Final results from the study, in which Roche and the Breast International Group are assessing the benefits of adjuvant Herceptin treatment in this group of patients, are due in 2011.

Roche’s life cycle leader for Herceptin, Peter Braun, indicated that the treatment, which generated sales of 5.1 billion Swiss francs ($4.41 billion) in 2008, has the potential for further growth in the years ahead, particularly in emerging markets. Regarding competition from GlaxoSmithKline’s Tyverb (lapatinib), Braun suggested Herceptin presents “quite a high hurdle,” noting that, thus far, GlaxoSmithKline appears to have “over-promised, and under-delivered.”

GlaxoSmithKline spokesperson Stephen Rea remarked that the UK drugmaker anticipates Tyverb use will increase over time and as additional data become available.

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Data presented at the San Antonio Breast Cancer Symposium provide evidence that patients with early-stage HER2-positive breast cancer whose tumours are one centimetre or smaller are at significant risk of recurrence, compared to those with early-stage disease who do not express the protein. “The findings indicate that physicians need to consider offering these women Herceptin-based therapy [trastuzumab] in the post-operative, or adjuvant setting,” stated the study’s senior author Ana Gonzalez-Angulo.

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For the retrospective study, researchers analysed the medical records of 965 patients with tumours smaller than one centimetre who were treated between 1990 and 2002, and who had not received adjuvant chemotherapy or Herceptin. Of those, 98 patients had HER2-positive tumours. Results showed that five-year, recurrence-free survival among patients with HER2-positive breast cancer was 77.1 percent, versus 93.7 percent among those who did not express the protein. Moreover, patients with HER2-positive tumours had 2.68 times higher risk of recurrence and 5.3 times higher risk of distant recurrence than those with HER2-negative tumours. Analysis of records from a second cohort study of 350 patients from European institutions confirmed the findings, researchers said.

Gonzalez-Angulo noted that “most physicians do not treat these small tumours with Herceptin,” adding that current treatment guidelines do not recommend additional therapy after surgery and radiation if tumours are less than five millimeters, while Herceptin-based adjuvant therapy should be “discussed” with patients if tumour size is from six millimeters to 10 millimeters. “This data strongly suggests that we need to rethink how we treat early-stage breast cancer patients with HER2 positive tumours and likely offer anti-HER2 therapy in the adjuvant setting,” Gonzalez-Angulo said.

Powel Brown of Baylor College of Medicine commented: “The implication would be that [patients] might benefit from treatment,” however that was not evaluated in the currect research, he said, adding that the findings need to be corroborated in larger studies. Herceptin is sold by Genentech in the US and by Roche in other markets.

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Roche stated Wednesday that it will present trial results at the San Antonio Breast Cancer Symposium showing that its oncology drugs Herceptin (trastuzumab), Avastin (bevacizumab) and Xeloda (capecitabine) improved outcomes in patients with breast cancer.

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The drugmaker indicated that results from the Phase III NOAH study demonstrate that women with locally advanced HER2-positive breast cancer, who were treated with Herceptin in combination with standard chemotherapy before surgery, experienced significantly improved disease-free survival three years after initiation of treatment, compared with patients who received pre-operative chemotherapy alone. In addition, preliminary data from an independent study conducted in Finland and Sweden suggest that oral Xeloda may decrease the recurrence of the disease in patients with early breast cancer, as well as improve overall survival.

Finally, the company will release initial efficacy findings from the “largest ever safety study of Avastin in a real-life setting,” involving more than 2000 patients with locally recurrent or metastatic breast cancer. The data show that the treatment can be used with a broad range of chemotherapy regimens, providing patients with a median progression-free survival of almost 10 months, Roche noted.

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