Exelixis (EXEL) announced positive results from the METEOR Phase 3 Pivotal Trial of Cabozantinib in advanced renal cell carcinoma, which was presented at the European Cancer Congress 2015. In the study, Cabozantinib met the primary endpoint of improving progression-free survival as compared to Evorulimus.
The drug, which has already been approved and marketed for thyroid cancer has also demonstrated a strong trend towards improving overall survival as compared to everolimus at an interim analysis.
The results that have been published in The New England Journal of Medicine and have been presented on Saturday September 26, during the Presidential Session I at the European Cancer Congress (ECC) 2015, which is being held September 25-29 in Vienna.
Exelixis expects to to file for approval in the U.S. and Europe by end of 2015 and early 2016, respectively.
Indeed, the results from the phase 3 of the METEOR pivotal trial, which compared cabozantinib to everolimus in 658 patients with renal cell carcinoma (RCC) were positive, especially considering the fact that the trial was conducted on RCC patients whose cancer has progressed following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).
In July 2015, Exelixis had disclosed that the trial met its primary endpoint, demonstrating a statistically significant increase in progression-free survival for patients in the cabozantinib arm.
The METEOR data and an accompanying editorial are published in The New England Journal of Medicine.
Per the trial protocol, the primary analysis was conducted on the first 375 patients randomized to ensure sufficient follow up and a PFS profile that would not be primarily weighted toward early events. The median PFS was 7.4 months for the cabozantinib arm versus 3.8 months for the everolimus arm, corresponding to a 42% reduction in the rate of disease progression or death for cabozantinib as compared to the everolimus arm.
In a post-hoc subset analysis of patients who had received sunitinib, the most commonly used first-line therapy, as their only prior VEGF receptor TKI, the median PFS for cabozantinib-treated patients (n=76) was 9.1 months versus 3.7 months for everolimus-treated patients. This corresponds to a 59% reduction in the rate of disease progression or death for patients treated with cabozantinib.
Toni K. Choueiri, M.D., clinical director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and METEOR’s principal investigator said: “In the METEOR trial, cabozantinib significantly improved progression-free survival as compared to everolimus, a commonly-used standard of care, in both the full study population for the primary endpoint analysis as well as in the subgroup of patients previously treated with sunitinib only. Cabozantinib was also associated with a safety profile similar to other VEGF receptor TKIs used to treat renal cell carcinoma. Uniquely, treatment with cabozantinib resulted in a strong trend towards improving overall survival, which is unprecedented as compared with other studies to date evaluating TKIs. The totality of the data support cabozantinib as a potential new treatment option for RCC patients whose disease has progressed following VEGF receptor-targeting therapy.”
Overall survival (OS): Data pertaining to OS in the entire study population of 658 patients, which is a secondary endpoint of the trial, were immature at the data cutoff. As previously announced, a pre-specified interim analysis triggered by the primary analysis for PFS showed a strong trend in OS favoring cabozantinib. At the time of the interim analysis of the OS, the p-value of 0.0019 to achieve statistical significance was not reached, and the trial will continue to the final analysis of OS anticipated in 2016.
Objective response rate (ORR): another secondary endpoint, was significantly higher with cabozantinib (21%) as compared with everolimus (5%; p < 0.001).
Treatment discontinuations for adverse events unrelated to progressive disease: 9% for cabozantinib and 10% for everolimus, respectively.
Michael M. Morrissey, Ph.D., Exelixis’ president and chief executive officer believes that the results of the METEOR trial suggest that cabozantinib has the potential to become a new and differentiated treatment option for patients with renal cell carcinoma who have progressed following VEGF receptor tyrosine kinase therapy, the most commonly-utilized treatment in the first-line setting.
We believe in the same and we expect that the firm will not lose time before sharing the results
with regulators in the United States and European Union. The firm has promised to complete its U.S. NDA filing by the end of this year, where cabozantinib has received Breakthrough Therapy Designation, and expects a European filing to follow in early 2016.
We look forward to advancing these regulatory processes in hopes of bringing cabozantinib to the renal cell carcinoma community as soon as possible.”
The question is: Do we dare accumulate EXEL at this time, i.e., the negative market in general and towards the biotech sector in special?
Our answer is yes. Definitely yes. Exelixis current low value is a casualty of the market analysts who weigh the value of firms only in terms of revenues and incomes, totally ignoring the value of their science, technology and pipeline products. EXEL is one of the stocks that were devastated by this practice and the people who practice it, which led many investors to miss great investment opportunities during the short life of the great biotech industry.
A few days ago, the European CHMP announced positive opinion for Exelixis’ drug Cobimetinib in combination with Vemurafenib for the advanced melanoma. Instead of rallying EXEL was subjected to a selloff of the stock. This is how investors are affected by negative analysts and spreading fear is like spraying fire.
Do we expect EXEL to rally right away?
It should rally quickly, but no. We do not expect it to happen. What we expect that those who have and continue to contribute to EXEL’s selloff will regret it in the near future.
Exelixis will soon have two products approved for three cancers in 2016. No firm has ever had treatments for three cancer on the market and remained worth less than $5 billion in market CAP.
Exelixis is an oncology firm and its small molecule pipeline products are promising, especially now that the practice of cancer diagnosis and treatment have totally changed. Oncologists have already treating cancer patients based on their cancers’ genomic mutations with drugs targeting specific proteins on newly discovered pathways of the cancers. Indeed, oncologists are beginning to treat cancer patients in a personalized way.
Exelixis is well prepared and well-equipped to satisfy the oncologists.
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