Strong Showing for Onyx, Amgen at European Cancer Meeting: BioBuzz
EMERYVILLE, Calif. (
) --Detailed data released Sunday from the phase IIb study of
Onyx Pharmaceuticals'
(ONXX)
cancer drug Nexavar in metastatic breast cancer patients looks really strong.
Recall that in July, Onyx announced that Nexavar
extended progression-free survival (PFS)
in this study. Well, the actual PFS benefit for Nexavar is 2.3 months, according to the late-breaker abstract for the study released Sunday to attendees at the
European Society for Medical Oncology
(ESMO) meeting in Berlin.
This study enrolled a mixture of first-line and second-line metastatic breast cancer patients. The median PFS for Nexavar plus Xeloxa was 6.4 months compared to a PFS of 4.1 months for Xeloda alone. Xeloda is an oral cancer drug marketed by
Roche
.
Investors should view favorably any PFS benefit above two months in favor of Nexavar. This is the first study to demonstrate that an oral, targeted cancer drug could significantly improve time to tumor growth.
By comparison, the combination of
Roche's
Avastin and Xeloda improved PFS by 2.9 months compared to Xeloda alone in the previously presented Ribbon-1 study. This study enrolled only first-line metastatic breast cancer patients.
More details from the Nexavar study will be presented on Wednesday, including a breakdown of results between first-line and second-line patients. Nexavar, which Onyx co-markets with
Bayer
is already approved for the treatment of kidney cancer and liver cancer. The companies are moving ahead on other breast cancer studies in light of these new data.
Onyx shares closed Friday at $34.27
Amgen's Denosumab Cancer Data Positive
Cancer data from clinical trials of
Amgen's
(AMGN) - Get Report
experimental bone drug denosumab is also trickling out of the ESMO meeting in Berlin, and so far, the results look positive for the drug.
Denosumab did not cause an increase in tumor progression compared to Roche's Zometa in a phase III study of metastatic breast cancer patients, according to a late-breaker abstract available to attendees at the European Society for Medical Oncology (ESMO) meeting in Berlin.
What this means is that denosumab did not cause tumor growth in these advanced breast cancer patients -- an important safety hurdle that the drug appears to have cleared quite strongly.
Last July, Amgen reported that denosumab was superior to Zometa in
preventing fractures and other bone-related problems
-- the primary efficacy endpoint of this study. Additional details in the ESMO abstract from this weekend confirmed this finding.
Detailed data is also being presented this morning from a second denosumab cancer study, this one in patients with solid tumors (excluding breast and prostate cancer) and multiple myeloma. The
were previously reported by Amgen in August.
The median time to first on-study skeletal-related event was 20.6 months for denosumab compared to 16.3 months for Zometa. The non-inferior result demonstrated a strong trend in favor of denosumab but just missed statistical significance for superiority, with a p value of 0.06.
Denosumab is designed to prevent or delay the destruction of bone in cancer patients. When cancer spreads to the bone – known as a bone metastases -- the growing cancer cells weaken and destroy the bone around the tumor. This damage can result in a number of serious bone complications, collectively called skeletal related events.
-- Reported by Adam Feuerstein in Boston
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