ALAMEDA, Calif. - Exelixis, Inc. (NASDAQ: NASDAQ:EXEL) has presented final data from its phase 3 CABINET trial, which evaluated cabozantinib (CABOMETYX®) against placebo in patients with advanced neuroendocrine tumors (NET). The study showed significant improvement in progression-free survival (PFS) for those treated with cabozantinib. These findings were shared at the European Society for Medical Oncology Congress (ESMO 2024) and concurrently published in the New England Journal of Medicine (NEJM).
The CABINET trial, conducted through the National Cancer Institute's National Clinical Trials Network, included patients with advanced pancreatic neuroendocrine tumors (pNET) and extra-pancreatic NET (epNET). Results indicated a marked increase in median PFS for cabozantinib-treated patients compared to those given a placebo. Specifically, the pNET cohort saw a median PFS of 13.8 months versus 4.4 months for placebo, while the epNET cohort had a median PFS of 8.4 months compared to 3.9 months with placebo.
Objective response rates (ORR) also favored cabozantinib, with 19% in the pNET cohort and 5% in the epNET cohort, against 0% with placebo in both groups. Interim overall survival (OS) rates were similar between cabozantinib and placebo, suggesting the drug's potential as a new treatment option for advanced NET.
The trial's safety profile for cabozantinib was consistent with its known risks, with no new safety concerns identified. Most patients required dose modifications to manage adverse events. Based on these results, Exelixis filed a supplemental New Drug Application (sNDA) with the FDA for cabozantinib as a treatment for advanced NET, which the FDA accepted in August with a target action date of April 3, 2025.
Exelixis emphasizes the potential of cabozantinib to significantly delay disease progression in patients with advanced NET, a condition with few existing treatment options and a poor prognosis. The company is collaborating with the FDA to expedite the availability of cabozantinib to patients in need.
This article is based on a press release statement and aims to provide a factual report on the CABINET trial's outcomes and the ongoing regulatory process for cabozantinib as a treatment for advanced neuroendocrine tumors.
In other recent news, Exelixis has maintained its Buy rating from H.C. Wainwright, Citi, BofA Securities, and Truist Securities, following the presentation of results from the Phase 3 CONTACT-02 trial at the European Society for Medical Oncology. The study, which assessed a combination therapy for patients with metastatic castration-resistant prostate cancer, demonstrated a statistically significant improvement in progression-free survival. This promising data supports the decision to uphold a Buy rating and price targets ranging from $29 to $33 on Exelixis shares.
Exelixis has also been making significant strides in its financial performance, reporting robust second-quarter earnings with revenues reaching $637.2 million, largely driven by its leading product, cabozantinib, which contributed $437.6 million. The company's diluted net income of $0.77 per share notably surpassed earlier projections.
Furthermore, Exelixis is awaiting an imminent decision on a patent dispute over its drug Cabometyx. This decision will determine the market exclusivity period for Cabometyx, and is crucial for the company's financial outlook.
Lastly, the company's supplementary New Drug Application (NDA) for cabozantinib in the treatment of neuroendocrine tumors (NET) has been accepted by the FDA, with a PDUFA date set for April 2025. These developments underscore the potential of Exelixis' ongoing endeavors and their possible impact on the company's future market performance.
InvestingPro Insights
As Exelixis, Inc. (NASDAQ: EXEL) continues to make strides in the oncology field with its promising trial results for cabozantinib, investors may find the company's financial health and market performance equally compelling. InvestingPro data shows a robust market capitalization of $7.55 billion, reflecting investor confidence in the company's growth prospects. The revenue growth is particularly notable, with a significant increase of 17.48% over the last twelve months as of Q2 2024, and an even more impressive quarterly surge of 35.61% in Q2 2024.
Exelixis's commitment to shareholder value is evident in its aggressive share buyback strategy, an InvestingPro Tip that often signals management's belief in the company's undervalued stock price. Additionally, the company's solid financial positioning is underscored by another InvestingPro Tip, revealing that it holds more cash than debt on its balance sheet, providing a cushion for future investments or to weather economic downturns.
The company's P/E ratio of 22.91, adjusted to 20.02 for the last twelve months as of Q2 2024, suggests that the stock is trading at a reasonable valuation relative to near-term earnings growth. Furthermore, a low PEG ratio of 0.17 during the same period indicates potential for even greater earnings growth relative to its current share price. These metrics, combined with the fact that analysts have recently revised their earnings estimates upwards for the upcoming period, suggest a positive outlook for the company's financial performance.
For readers interested in a deeper dive into Exelixis's financials and market performance, InvestingPro offers additional tips that could provide further insights into the company's investment potential. There are currently 13 additional InvestingPro Tips available for Exelixis, which can be accessed through the dedicated InvestingPro product page.
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