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 Roche has sought to shield its lucrative breast cancer franchise
from cheaper copies of its drugs by showing the combination would
provide a greater benefit.
After surgery to remove their tumors, nearly 5,000 women with
HER2-positive, early breast cancer were treated with either
chemotherapy followed by a year of standard treatment with Roche's
Herceptin and the newer drug, Perjeta, or with Herceptin and a
placebo.
After three years, 93.2 percent of women on Herceptin alone had not
developed invasive cancer compared with 94.1 percent of those given
Perjeta - a difference of less than one percentage point. For
patients whose disease had not spread to lymph nodes, Perjeta did
not make a difference, the researchers said.
Both Perjeta and Herceptin are antibody drugs used for breast cancer
patients whose tumors generate a protein called HER2, accounting for
around 25 percent of breast cancer cases.
Cancer specialists said the early results indicate that doctors
should consider adding Perjeta only for post-surgery patients with
the worst prognosis - cancer that has spread to the lymph nodes or
cancer not eligible for hormone therapies.
"For those patients who do have a worse anatomic prognosis, the
combination is probably better than the single agent," said Dr.
Bruce Johnson, chief clinical research officer at Boston's
Dana-Farber Cancer Institute and the American Society of Clinical
Oncology's (ASCO) incoming president.
Roche executives said the trial, slated to run for 10 years, will
likely show a wider advantage for Perjeta over time.
Daniel O'Day, head of pharmaceuticals at Roche, estimated that 70
percent, or 350,000, of breast cancer patients are diagnosed as
"high-risk," meaning their cancer has spread or does not respond to
hormone therapy.
The U.S. list price for a one-year course of the Perjeta/Herceptin
regimen in the post-surgery setting is around $158,000, while
Herceptin alone costs around $74,500.
Serious side effects seen in the trial included heart failure or
heart-related death in 0.7 percent of patients in the Perjeta group
and 0.3 percent of the placebo group.
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In March, Roche said the trial found that the Perjeta cocktail kept
patients alive longer, but full details were released here on Monday
at the annual ASCO meeting.
"It's clear this approach may not be advantageous for women with a
lower risk for recurrence," said Dr. Harold Burstein, a clinical
investigator at Dana-Farber's Breast Oncology Center, who was not
involved in the study.
The study researchers said they are trying to find biomarkers that
may predict which patients benefit from Perjeta as well as doing
research to see if the length of treatment could be shortened to six
months.
Herceptin, approved in 1998, is losing patent protection, exposing
it to eventual competition. A partnership of Mylan NV and Biocon Ltd
has filed for U.S. and European Union approval of their biosimilar
version, while Celltrion Inc and Samsung Bioepis Co, a joint venture
of Samsung Biologics Co and Biogen Inc, are each seeking approval in
Europe.
Roche said it expects competition from biosimilar Herceptin in
Europe late this year, but patent coverage will prevent a U.S.
version until 2019.
(Reporting by Deena Beasley; Editing by Phil Berlowitz)
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