Exelixis (EXEL) Says Data from Trials of Cabozantinib and Cobimetinib Will be Subject of 15 Presentations at ESMO

August 31, 2016 8:35 AM EDT

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Exelixis, Inc. (NASDAQ: EXEL) today announced that data from clinical trials of cabozantinib and cobimetinib will be the subject of 15 presentations at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, October 7 – 11, 2016.

Detailed results from CABOSUN, a randomized phase 2 clinical trial of cabozantinib compared with sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC), will be presented at ESMO as a late-breaking abstract in the Genitourinary Tumours, Non-Prostate oral presentation session on Saturday, October 8. Additional poster presentations will detail the investigation of cabozantinib in other cancer settings, including in combination with nivolumab in metastatic urothelial carcinoma and other genitourinary cancers, as well as the evaluation of cobimetinib in combination studies across multiple tumor types.

“This year’s ESMO Congress provides Exelixis and our partners with the opportunity to present data across a broad spectrum of cancers and potential treatment combinations,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We look forward to the first presentation of the CABOSUN data, which will provide more detail about the statistically significant and clinically meaningful improvement in progression-free survival for cabozantinib in patients with advanced renal cell carcinoma in the front-line setting. Our focus remains on further examining the potential of our therapies and moving these medicines through clinical development so they are available to patients and physicians as quickly as possible.”

Cabozantinib to be featured in eight presentationsThe full schedule of cabozantinib presentations expected at the meeting is as follows:

Oral Presentation[LBA30] “CABOzantinib versus SUNitinib (CABOSUN) as initial targeted therapy for patients with metastatic renal cell carcinoma (mRCC) of poor and intermediate risk groups: Results from ALLIANCE A031203 Trial.”Dr. Toni Choueiri, Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USASession: Genitourinary Tumours, Non-ProstateOral presentation Saturday, October 8, 9:15 – 9:30 a.m. CEST, MadridNote: This is a National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP) study.

Poster Discussion[774PD] “A phase I study of cabozantinib plus nivolumab (CaboNivo) in patients (pts) with refractory metastatic urothelial carcinoma (mUC) and other genitourinary (GU) tumors.”Dr. Andrea Borghese Apolo, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USASession: Genitourinary Tumours, Non-ProstatePoster presented Sunday, October 9, 4:30 – 5:30 p.m. CEST, AthensNote: This is an NCI-CTEP study.

Poster Presentations[787P] “A phase II study of cabozantinib in patients (pts) with relapsed/refractory metastatic urothelial carcinoma (mUC).”Dr. Rosa Nadal, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USASession: Genitourinary Tumours, Non-ProstatePoster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall ENote: This is an NCI-CTEP study.

[814P] “Efficacy of cabozantinib (cabo) vs everolimus (eve) by metastatic site and tumor burden in patients (pts) with advanced renal cell carcinoma (RCC) in the phase 3 METEOR trial.”Dr. Thomas Powles, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free NHS Trust, London, GBSession: Genitourinary Tumours, Non-ProstatePoster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E

[815P] “Evaluation of the novel “trial within a trial” design of METEOR, a randomized phase 3 trial of cabozantinib versus everolimus in patients (pts) with advanced renal cell carcinoma (RCC).”Colin Hessel, Exelixis, Inc., South San Francisco, California, USASession: Genitourinary Tumours, Non-ProstatePoster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E

[816P] “Quality of life (QoL) in the phase 3 METEOR trial of cabozantinib vs everolimus for advanced renal cell carcinoma (RCC).”Dr. David Cella, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USASession: Genitourinary Tumours, Non-ProstatePoster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E

[818P] “Analysis of regional differences in the phase 3 METEOR study of cabozantinib (cabo) versus everolimus (eve) in advanced renal cell carcinoma (RCC).”Dr. Nizar Tannir, University of Texas, MD Anderson Cancer Center, Houston, Texas, USASession: Genitourinary Tumours, Non-ProstatePoster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E

[1421TiP] “A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in high grade undifferentiated uterine sarcoma (HGUS) after stabilization or response to doxorubicin +/- ifosfamide following surgery or in metastatic first line treatment.”Dr. Isabelle Ray-Coquard, Cancer Research Center of Lyon, Lyon, FranceSession: SarcomaPoster presented Monday, October 10, 1 – 2 p.m. CEST, Hall ENote: This is an investigator-sponsored trial.

Cobimetinib to be featured in seven presentationsAlso at the meeting, Exelixis’ collaborator Genentech, a member of the Roche Group, will present data on cobimetinib, an Exelixis-discovered compound, in disease settings including metastatic colorectal cancer, melanoma and breast cancer. The full schedule of cobimetinib presentations expected at the meeting is as follows:

Oral Presentation[1111O] “Genomic features of complete responders (CR) versus fast progressors (PD) in patients with BRAFV600-mutated metastatic melanoma treated with cobimetinib + vemurafenib or vemurafenib alone.”Y. Yan, Genentech, Inc., South San Francisco, California, USASession: Melanoma and Other Skin TumoursOral presentation Saturday, October 8, 3:00 – 3:15 p.m. CEST, Copenhagen

Poster Discussion[1109PD] “Preliminary safety and clinical activity of atezolizumab combined with cobimetinib and vemurafenib in BRAF V600-mutant metastatic melanoma.”Dr. Patrick Hwu, MD Anderson Cancer Center, Houston, Texas, USASession: Melanoma and Other Skin TumoursPoster presented Monday, October 10, 11 a.m. – 12 p.m. CEST, Rome

Poster Presentations[470P] “Efficacy and safety of cobimetinib (cobi) and atezolizumab (atezo) in an expanded phase 1B study of microsatellite-stable (MSS) metastatic colorectal cancer (mCRC).”Dr. Jayesh Desai, Peter MacCallum Cancer Centre, Melbourne, AustraliaSession: Genitourinary Tumours, ColorectalPoster presented Saturday, October 8, 1– 2 p.m. CEST, Hall E

[1142P] “Prognostic subgroups and impact of treatment for post-progression overall survival (ppOS) in patients (pts) with BRAFV600-mutated metastatic melanoma treated with decarbazine (DTIC) or vemurafenib (VEM) +/- cobimetinib (COBI): A pooled analysis.”Dr. Paolo Ascierto, National Tumor Institute “Fondazione G. Pascale,” Naples, ItalySession: Melanoma and Other Skin TumoursPoster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E

[1138P] “Cobimetinib plus vemurafenib to treat unresectable or metastatic melanoma: Data from the French temporary authorization for use.”Dr. Nicolas Meyer, Institute Claudius Regaud, Toulouse, FranceSession: Melanoma and Other Skin TumoursPoster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E

[1156TiP] “CONVERCE: Evaluation of cobimetinib and vemurafenib combination treatment in patients with brain metastases from BRAFV600 mutated melanoma.”Dr. Thierry Lesimple, Centre Eugène Marquis, Rennes, FranceSession: Melanoma and Other Skin TumoursPoster presented Sunday, October 9, 1 – 2 p.m. CEST, Hall E

[286P] “First-line cobimetinib (C) + paclitaxel (P) in patients (pts) with advanced triple-negative breast cancer (TNBC): Updated results and tumoral immune cell infiltration data from the phase 2 COLET study.”Dr. David Miles, Mount Vernon Cancer Centre, Northwood, United KingdomSession: Breast Cancer, Locally Advanced and MetastaticPoster presented Monday, October 10, 1– 2 p.m. CEST, Hall E

About the CABOSUN Study

On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS compared with sunitinib in patients with advanced intermediate- or poor-risk RCC. CABOSUN is being conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP). Exelixis is discussing the results with regulatory authorities and evaluating potential next steps in the development and submission strategy for cabozantinib as a first-line treatment for patients with advanced RCC.

CABOSUN is a randomized, open-label, active-controlled phase 2 trial that enrolled 157 patients with advanced RCC determined to be intermediate- or poor-risk by the International Metastatic RCC Database Consortium (IMDC) criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, 4 weeks on followed by 2 weeks off). The primary endpoint was progression-free survival. Secondary endpoints included overall survival and objective response rate. Eligible patients were required to have locally advanced or metastatic clear-cell RCC, ECOG performance status 0-2, and had to be intermediate or poor risk, per the IMDC Criteria (Heng JCO 2009). Prior systemic treatment for RCC was not permitted.



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