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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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METEOR is the company’s phase 3 pivotal trial of cabozantinib in mRCC. Enrollment was completed in November 2014, and the protocol specifies that the analysis of the primary endpoint, progression-free survival (PFS), will be conducted once 259 events have occurred among the first 375 patients enrolled. Exelixis previously stated that top-line results from METEOR were anticipated to be available in the second quarter of 2015; however, because the rate at which events associated with the primary endpoint of PFS are accumulating has slowed, the company now anticipates top-line results will be available at the end of the second quarter or early in the third quarter of this year.
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Source: press release, 4/30/15. http://www.exelixis.com/investors-media/press-releases?cpurl=http%3A%2F%...

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Exelixis’ Cabozantinib Granted Fast Track Designation by FDA For Advanced Renal Cell Carcinoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Apr. 9, 2015-- Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. Cabozantinib is the company’s lead compound and inhibits the activity of multiple tyrosine kinases including MET, VEGFRs and RET. The FDA created the Fast Track process to facilitate the development and expedite the review of drugs to treat serious diseases and address unmet medical needs. Fast Track designation confers important benefits, including the potential eligibility for Priority Review of a New Drug Application, if relevant criteria are met.1

Cabozantinib is the subject of METEOR, an ongoing phase 3 pivotal trial in patients with metastatic RCC who have experienced disease progression following treatment with at least one VEGFR tyrosine kinase inhibitor. Patients are randomized 1:1 to receive 60 mg of cabozantinib daily or 10 mg of everolimus daily. The primary endpoint of METEOR is progression-free survival, and secondary endpoints include overall survival and objective response rate. Exelixis expects to release top-line results from the trial in the second quarter of 2015. In addition to the metastatic RCC development program, Exelixis is also evaluating cabozantinib in CELESTIAL, a phase 3 pivotal trial in second-line hepatocellular carcinoma (HCC).
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Source: press release, 4/09/15. http://www.exelixis.com/investors-media/press-releases

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Exelixis Completes Enrollment of the METEOR Phase 3 Pivotal Trial of Cabozantinib in Metastatic Renal Cell Carcinoma
-- Top-Line Data from METEOR Expected in Q2 2015 --

-- Primary Analysis of PFS Endpoint to Be Conducted on First 375 Patients Enrolled --

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 6, 2014-- Exelixis, Inc. (NASDAQ:EXEL) today announced that the enrollment target of 650 patients has been reached for METEOR, the company’s phase 3 pivotal trial of cabozantinib in patients with metastatic renal cell carcinoma (RCC) who have experienced disease progression following treatment with at least one VEGFR tyrosine kinase inhibitor (TKI). Top-line efficacy and safety data from METEOR are now expected in the second quarter of 2015.

“METEOR was designed to evaluate cabozantinib’s potential as a treatment for metastatic renal cell carcinoma, an aggressive form of the disease that is usually incurable,” said Toni Choueiri, MD, clinical director of the Lank Center for Genitourinary Oncology and director of the kidney cancer center, Dana-Farber Cancer Institute. “Recent drug development efforts in RCC have focused on single targets, but there is a compelling body of evidence suggesting a potential advantage in targeting the VEGFR and MET signaling pathways simultaneously. Since cabozantinib inhibits both of these pathways, this trial provides an exciting test of this hypothesis.”

Michael M. Morrissey, Ph.D., President and CEO of Exelixis, commented: “With enrollment in METEOR completed, Exelixis has achieved one of its major objectives for the second half of the year. We are grateful for the oncology community’s interest and support, as reflected in the trial’s rapid enrollment, and we look forward to delivering top-line results from METEOR in the second quarter of 2015.”
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Source: press release, 11/06/14. http://www.exelixis.com/investors-media/press-releases

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Gisela M. Schwab, MD, EVP and CMO, gave guidance for data from the Cabozantinib RCC and HCC programs. She stated, "We are very encouraged by the enthusiasm for these trials in the medical community, both studies are off to a good start and we hope to see top-line data on RCC in 2015 and on HCC in the 2016 or 17 time-frame."
Source: Q4 2013 earnings conference call, 2/20/14.

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Exelixis Initiates Phase 3 Pivotal Trial of Cabozantinib in Patients With Metastatic Renal Cell Carcinoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May. 31, 2013-- Exelixis, Inc. (NASDAQ:EXEL) today announced it has initiated METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with metastatic renal cell carcinoma (mRCC) who have experienced disease progression following treatment with at least one prior VEGFR tyrosine kinase inhibitor (TKI). The primary endpoint for the trial is progression-free survival.

“RCC patients who progressed after or who are refractory to initial treatment with VEGFR-TKI therapy have limited treatment options,” said METEOR Principal Investigator Toni K. Choueiri, M.D., Director of the Kidney Cancer Center at the Dana-Farber Cancer Institute and an Associate Professor of Medicine at Harvard Medical School. “The cabozantinib data to date in RCC patients previously treated with VEGFR-TKIs showed encouraging anti-tumor activity, and provide a sound rationale for the design of the METEOR phase 3 study comparing cabozantinib to everolimus in this indication.”

METEOR is an open-label trial of cabozantinib in patients with mRCC that is being conducted at up to 200 sites in up to 26 countries. The trial is expected to enroll 650 patients with clear cell RCC who have received and progressed on at least one VEGFR-TKI. Patient enrollment will be weighted toward Western Europe, North America, and Australia, and patients will be stratified based on the number of prior VEGFR-TKI therapies received and commonly applied RCC risk criteria developed by Motzer et al. Patients will be randomized 1:1 to receive 60 mg of cabozantinib daily or 10 mg of everolimus daily. No cross-over is allowed between the study arms.

The primary endpoint is progression-free survival (PFS) and the secondary endpoint is overall survival (OS). Exploratory endpoints include patient-reported outcomes, biomarkers, safety, and pharmacokinetics. PFS is an established acceptable endpoint for RCC clinical trials and has been used to support approval of sorafenib, sunitinib, everolimus, axitinib, and pazopanib in this indication.

Based on available clinical trial data, the primary endpoint assumes a median PFS of 5 months for the everolimus arm and 7.5 months for cabozantinib arm. This provides for a hazard ratio (HR) of 0.67 and 90% power and requires 259 PFS events among the first 375 patients randomized. The secondary endpoint assumes a median OS of 15 months for the everolimus arm and 20 months for the cabozantinib arm. This provides for a HR of 0.75 and 80% power and requires 413 events.

“Initiation of this phase 3 pivotal trial in mRCC is an important component of our development strategy to expand the cabozantinib franchise by exploring additional indications with the goal of providing patients with new treatment options,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “Our pre-phase 3 meetings with regulatory authorities in the U.S. and Europe, as well as feedback gathered from expert oncologists around the globe, have helped us design a trial that is intended to provide for a robust examination of cabozantinib’s clinical potential as a treatment for mRCC. We also remain on track to begin a phase 3 pivotal trial of cabozantinib in patients with metastatic hepatocellular carcinoma in the third quarter of this year.”
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http://www.exelixis.com/investors-media/press-releases

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A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy
Estimated Enrollment: 650
Study Start Date: June 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
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Souorce: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01865747?term=Cabozantinib&phase=2...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Cabozantinib - Renal cell carcinomaUrologyRenal cell carcinomaTyrosine kinase inhibitorc-Met and VEGFR-2

Mechanism of action: Cabozantinib is an orally bioavailable, small molecule receptor tyrosine kinase (RTK) inhibitor with potential antineoplastic activity. Cabozantinib strongly binds to and inhibits several tyrosine receptor kinases. Specifically, cabozantinib appears to have a strong affinity for the hepatocyte growth factor receptor (Met) and vascular endothelial growth factor receptor 2 (VEGFR2), which may result in inhibition of tumor growth and angiogenesis, and tumor regression. This agent has also been shown to inhibit mast/stem cell growth factor (KIT), FMS-like tyrosine kinase 3 (Flt3) and tyrosine-protein kinase receptor (Tie-2).

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2015-06-01 - 2015-07-31

Results:

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Exelixis and Its Partner Ipsen Announce Positive Overall Survival Results from Subgroup Analyses of Phase 3 Trial of CABOMETYX™ (cabozantinib) Tablets in Advanced Renal Cell Carcinoma at 2016 ASCO Annual Meeting
- Additional data from pivotal METEOR trial underscore clinically meaningful benefit of CABOMETYX across subgroups of patients -

SOUTH SAN FRANCISCO, Calif. & PARIS--(BUSINESS WIRE)--Jun. 6, 2016-- Exelixis, Inc. (NASDAQ:EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced the presentation of positive data from subgroup analyses of the pivotal METEOR trial comparing CABOMETYX™ (cabozantinib) tablets with everolimus in 658 patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. The data will be presented in two posters today at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held June 3-7 in Chicago, by Bernard Escudier, M.D., chair, Genitourinary Oncology Committee, Institut Gustave Roussy and Thomas Powles, M.D., clinical professor of genitourinary oncology, Barts Cancer Institute. The findings demonstrate that benefits of CABOMETYX in progression-free survival (PFS) and overall survival (OS) were independent of the presence of bone metastases, prior anti-PD-1/PD-L1 therapy, and the type of prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.

“These additional analyses demonstrate the value of CABOMETYX for advanced kidney cancer, showing consistent improvement in PFS and OS across multiple subgroups of patients in the METEOR trial,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We are dedicated to exploring the full potential of CABOMETYX to help as many patients as possible.”

In the first of the two presentations, treatment with CABOMETYX was associated with improved PFS and OS in patients who had bone metastases at baseline (n=142). Median PFS was 7.4 months with CABOMETYX versus 2.7 months with everolimus (HR=0.33, 95% CI 0.21-0.51), and median OS was 20.1 months versus 12.1 months, respectively (HR=0.54, 95% CI 0.34-0.84).

For patients who had both bone and visceral metastases (n=112), median PFS was 5.6 months with CABOMETYX and 1.9 months with everolimus (HR=0.26, 95% CI 0.16-0.43). Median OS was 20.1 months versus 10.7 months, respectively (HR=0.45, 95% CI 0.28-0.72). The safety profile of CABOMETYX for the subgroup with bone metastases was consistent with that of the overall METEOR trial.

“Patients whose kidney cancer has spread to their bones traditionally have a poorer prognosis and worse treatment outcomes compared with those who do not have bone involvement,” said Dr. Escudier. “CABOMETYX demonstrated a clinically meaningful benefit for those with bone metastases, which is encouraging for physicians and patients who are seeking additional therapeutic options.”

In the second presentation, outcomes were evaluated based on the prior therapy patients had received before entering the METEOR trial. OS and PFS benefits were consistent across all subgroups evaluated (see table below), including number of prior VEGFR TKIs (one or more than one), specific prior VEGFR TKI (sunitinib or pazopanib) in patients who had only one prior VEGFR TKI therapy, and prior treatment with anti-PD-1/PD-L1 therapies. Adverse events in the treatment subgroups were similar to those in the overall study population and were managed with dose reductions.

Table. OS and PFS in METEOR by Subgroup - http://www.exelixis.com/investors-media/press-releases

On April 25, 2016 CABOMETYX was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. CABOMETYX, which was granted Fast Track and Breakthrough Therapy designations by the FDA, is the first approved single agent therapy to demonstrate, in a phase 3 trial for patients with advanced RCC, robust and clinically meaningful improvements in all three key efficacy parameters — OS, PFS and objective response rate.

Please see Important Safety Information below and full U.S. prescribing information for CABOMETYX™ (cabozantinib) tablets at https://cabometyx.com/downloads/cabometyxuspi.pdf
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Source: press release, 6/06/16. http://www.exelixis.com/investors-media/press-releases

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Exelixis Announces Positive Overall Survival Results from METEOR, the Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma

– Cabozantinib significantly improved overall survival as compared with everolimus –

– First therapy to demonstrate improvement in overall survival, progression-free survival, and objective response rate in a large, pivotal phase 3 study in previously treated renal cell carcinoma patients –

– Exelixis intends to share the data with U.S. and EU regulators, and to present the data at a medical meeting later in 2016 –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Feb. 1, 2016-- Exelixis, Inc. (NASDAQ:EXEL) today announced positive overall survival (OS) results from METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with advanced renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI). In a second interim analysis for OS, a secondary endpoint of the trial, the results showed a highly statistically significant and clinically meaningful increase in OS for patients randomized to cabozantinib as compared to everolimus. Ongoing study monitoring did not identify any new safety signals. Exelixis intends to present these data at a medical meeting later this year.

“With these results, cabozantinib is now the first and only therapy evaluated in a large, pivotal study in previously treated patients with advanced renal cell carcinoma to demonstrate a benefit in all three key efficacy parameters – overall survival, progression-free survival and objective response rate,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “This is an important moment for the kidney cancer community, including the patients, clinical investigators, and Exelixis team members who made the METEOR trial possible. Exelixis will share these new results with regulators as part of ongoing review processes in the United States and European Union. Our highest priority is to bring this new option for advanced RCC to patients as quickly as possible.”

In late December 2015, Exelixis announced that it completed the submission of its rolling New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced RCC who have received one prior therapy; the U.S. Food and Drug Administration (FDA) recently granted Priority Review to the application and set a Prescription Drug User Fee Act action date of June 22, 2016. The FDA previously granted Breakthrough Therapy and Fast Track designations to cabozantinib for its potential advanced RCC indication.

On January 28, 2016, the European Medicines Agency (EMA) validated Exelixis’ Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy. The MAA has been granted accelerated assessment, making it eligible for a 150-day review, versus the standard 210 days (excluding clock stops when information is requested by the EMA’s Committee for Medicinal Products for Human Use).

Both regulatory applications are based on the results of METEOR. In July 2015, Exelixis announced top-line results from METEOR demonstrating that the trial had met its primary endpoint of improving progression-free survival; compared with everolimus, a standard of care therapy for second line RCC, cabozantinib was associated with a 42% reduction in the rate of disease progression or death. Median PFS for cabozantinib was 7.4 months as compared to 3.8 months with everolimus (HR=0.58, 95% CI 0.45-0.75, p < 0.001). Cabozantinib also significantly improved the objective response rate as compared to everolimus. These data were later presented at the European Cancer Congress in September 2015 and concurrently published in The New England Journal of Medicine.

Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ® in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. COMETRIQ is not indicated for patients with RCC. In the METEOR trial, and all other cancer trials currently underway, Exelixis is investigating a tablet formulation of cabozantinib distinct from the COMETRIQ capsule form. The tablet formulation of cabozantinib is the subject of the NDA and MAA for advanced RCC.
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Source: press release, 2/01/16. http://www.exelixis.com/investors-media/press-releases

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Exelixis Announces Positive Results From Subgroup Analyses of the METEOR Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma to be Presented at ASCO 2016 Genitourinary Cancers Symposium
-- Data further underscore clinical benefit of cabozantinib across subgroups of patients with advanced renal cell carcinoma --

-- METEOR data are the foundation for the U.S. NDA filing submitted last month, EU filing planned for early 2016 --

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jan. 4, 2016-- Exelixis, Inc. (NASDAQ:EXEL) today announced the presentation of positive data from subgroup analyses of METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI). Cabozantinib treatment resulted in benefits in progression-free survival (PFS), the trial’s primary endpoint, and objective response rate (ORR), a secondary endpoint, across various prespecified and post-hoc analysis subgroups. Importantly, observed benefits were independent of the location and number of organ metastases, tumor burden, the type, duration and number of prior VEGF receptor TKI therapies, and prior PD-1/PD-L1 therapy.

Bernard Escudier, M.D., chair of the Genitourinary Oncology Committee at the Institut Gustave Roussy (Villejuif, France) and an investigator on the METEOR trial, summarized the results during a press briefing in advance of the American Society of Clinical Oncology 2016 Genitourinary Cancers Symposium (ASCO GU), which is being held January 7-9, 2016 in San Francisco. Dr. Escudier will formally present the data (Abstract #499) at ASCO GU during an oral presentation session starting at 2:45 p.m. PT on Saturday, January 9, 2016.

“In the METEOR trial, cabozantinib was previously associated with statistically significant improvements in progression-free survival and objective response rate as compared to everolimus, a standard of care in the second-line renal cell carcinoma treatment setting,” said Dr. Escudier. “This latest data set demonstrates that these benefits are favorable across a variety of prespecified and post-hoc subgroups, including patients who have received prior therapy with immune checkpoint inhibitors. In addition, cabozantinib was active in patients with low and high tumor burden, including patients with both bone and visceral metastases. Collectively, the data from METEOR suggest that cabozantinib could become an important addition to the renal cell carcinoma treatment landscape if approved.”

As previously announced, the METEOR trial met its primary endpoint of demonstrating a statistically significant increase in PFS for cabozantinib as compared to everolimus, as determined by an independent radiology committee. Per the trial protocol, the primary analysis was conducted among 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 for this population 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 everolimus (hazard ratio [HR]=0.58, 95% confidence interval [CI] 0.45-0.75, p<0.001). These data were later presented at the European Cancer Congress (ECC) in September 2015 and concurrently published in The New England Journal of Medicine.

The ASCO GU presentation will be the first to include PFS data from the METEOR trial’s entire 658-patient study population. As assessed by independent radiology committee, the median PFS across all enrolled patients was 7.4 months for the cabozantinib arm versus 3.9 months for the everolimus arm, corresponding to a 48% reduction in the rate of disease progression or death for cabozantinib as compared to everolimus (HR = 0.52, 95% CI 0.43-0.64, p<0.001).

Updated ORR results from the full 658-patient study population will also be presented at ASCO GU for the first time. As assessed by independent radiology committee, the ORR across all 658 patients was 17% for cabozantinib and 3% for everolimus. The median duration of response for cabozantinib was not reached (95% CI 7.2 months; not reached), as compared to 7.4 months (95% CI 1.9 months; not reached) for everolimus. As previously reported at the ECC in September 2015, the ORR for the first 375 patients enrolled was 21% for cabozantinib and 5% for everolimus.

Cabozantinib’s effects on PFS and ORR were favorable across patient subgroups including: ECOG performance status; commonly applied RCC risk criteria developed by Motzer et al.; organ involvement, including bone and overall tumor burden; extent and type of prior VEGF receptor TKI therapy; and prior PD-1/PD-L1 therapy. For patients without prior PD-1/PD-L1 therapy, median PFS was 7.4 months for cabozantinib and 3.9 months for everolimus (HR = 0.54, 95% CI 0.44-0.66). For patients who had received prior PD-1/PD-L1 therapy, the median PFS for cabozantinib was not reached, and the median PFS for everolimus was 4.1 months (HR = 0.22, 95% CI 0.07-0.65).

“These new METEOR subgroup analyses further underscore the potential for cabozantinib to significantly impact the treatment of renal cell carcinoma, an aggressive cancer for which patients and physicians need new options,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “These data were included in our New Drug Application with the U.S. Food and Drug Administration, filed last month, and we intend to include them in our upcoming European Union Marketing Authorization Application, which we expect to submit shortly. Additionally, in 2016 we await the final analysis for METEOR’s overall survival secondary endpoint.”

As previously reported, data pertaining to overall survival (OS) in the entire study population of 658 patients, a secondary endpoint of the trial, were immature at the data cutoff. A pre-specified interim analysis triggered by the primary analysis for PFS showed a strong trend in OS favoring cabozantinib (HR=0.67, 95% CI 0.51-0.89, p=0.005). At the time of the interim analysis, 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.

Safety data from the trial were consistent with what was previously presented and published.

Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ® in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. COMETRIQ is not indicated for patients with RCC. In the METEOR trial, and all other cancer trials currently underway, Exelixis is investigating a tablet formulation of cabozantinib distinct from the COMETRIQ capsule form. The tablet formulation of cabozantinib is the subject of Exelixis’ New Drug Application with the U.S. Food and Drug Administration for advanced RCC.
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Source: press release, 01/04/16. http://www.exelixis.com/investors-media/press-releases

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Exelixis Announces Positive Top-Line Results from METEOR, the Phase 3 Pivotal Trial of Cabozantinib versus Everolimus in Patients with Metastatic Renal Cell Carcinoma
- Study Met Primary Endpoint of Significantly Improving Progression-Free Survival -

- Cabozantinib Reduced the Risk of Disease Progression or Death by 42%; Hazard Ratio = 0.58, (p < 0.0001) Compared to Everolimus -

- Overall Survival Interim Analysis Showed a Trend Favoring Cabozantinib; Hazard Ratio = 0.67, (p = 0.005) Compared to Everolimus -

- Exelixis to Complete U.S. and EU Regulatory Filings in Early 2016 -

- Conference Call at 8:30 AM EDT / 5:30 AM PDT Today -

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jul. 20, 2015-- Exelixis, Inc. (NASDAQ:EXEL) today announced positive top-line results from the primary analysis of METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with metastatic renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).

The trial met its primary endpoint of demonstrating a statistically significant increase in progression-free survival (PFS) in the first 375 randomized patients as determined by an independent radiology committee (IRC). Cabozantinib reduced the risk of disease progression or death by 42 percent compared to the everolimus arm (hazard ratio [HR]=0.58, 95 percent CI 0.45-0.75, p<0.0001).

Data pertaining to overall survival (OS) in the entire study population of 658 patients, a secondary endpoint of the trial, were immature at the data cutoff. A prespecified interim analysis, triggered by the primary analysis for PFS, showed a trend in OS favoring cabozantinib (HR = 0.67, unadjusted 95 percent CI 0.51 - 0.89; p=0.005). At the time of the interim analysis, the pre-specified p-value of 0.0019 to achieve statistical significance was not reached. The trial will continue to the final analysis of OS anticipated in 2016.

METEOR’s primary analysis included a review of serious adverse event (SAE) data. Based on this analysis, the frequency of SAEs of any Grade regardless of causality was approximately balanced between study arms. The rate of treatment discontinuation due to adverse events was low (10%) in both study arms.

Detailed results of the trial will be submitted for presentation at an upcoming medical conference.

In April 2015, cabozantinib received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of advanced RCC patients who have received one prior therapy. Based on the outcome of METEOR, Exelixis plans to complete regulatory filings in the United States and European Union in early 2016.

“We are eager to offer new treatment options for patients with metastatic RCC, particularly in the second-line setting where the most commonly utilized therapies have demonstrated a uniformly modest progression-free survival benefit,” said Toni K. Choueiri, M.D., clinical director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and METEOR’s principal investigator. “The magnitude of the improvement in PFS observed with cabozantinib compared to everolimus in the METEOR trial is an exciting and important development — it suggests an opportunity to improve care and outcomes for patients with metastatic RCC.”

“The positive top-line results from METEOR represent strong progress for the kidney cancer community and for Exelixis, bringing us one step closer to our shared goal of delivering a new and meaningfully differentiated therapeutic option for the many metastatic RCC patients in need,” said Michael M. Morrissey, Ph.D., the company’s president and chief executive officer. “With these data now in hand, Exelixis’ highest corporate priority becomes the submission of U.S. and EU regulatory filings, which we intend to complete in early 2016.”

Dr. Morrissey continued, “Delivering these top-line results for METEOR is one of multiple clinical development and regulatory milestones that we have planned for this year. These milestones collectively have the potential to significantly enhance the opportunities before us and bring value to the multiple stakeholders we serve. We look forward to sharing the detailed results of METEOR with the oncology community at an upcoming medical conference, and we thank all of the patients, families, investigators, and clinical staff who made the trial possible.”

Conference Call and Webcast

Exelixis' management will host a conference call to discuss the METEOR results beginning at 8:30 a.m. EDT/ 5:30 a.m. PDT today, July 20, 2015. To join the call, participants may dial 877-358-0169 (domestic) or 706-679-2029 (international) and provide the conference call passcode 90168151 to join by phone. To listen to a live webcast of the conference call, visit the Event Calendar page under Investors & Media at www.exelixis.com.

An archived replay of the webcast will be available on the Event Calendar page under Investors & Media at www.exelixis.com for at least thirty days. An audio-only phone replay will be available until 11:59 p.m. EDT on July 22, 2015. Access numbers for the phone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 90168151.
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Source: press release, 7/20/15. http://www.exelixis.com/investors-media/press-releases

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