Press Release
Press Release
Cabozantinib and Cobimetinib to Be Featured in Fourteen Presentations at 2015 ASCO Annual Meeting
Cabozantinib will be the subject of eight presentations primarily from
studies conducted under the company’s Investigator-Sponsored Trial
program and collaboration with the National Cancer Institute’s Cancer
Therapy Evaluation Program (NCI-CTEP), as well as from one
Oral Presentations
-
Abstract 8003: “Cabozantinib (C), erlotinib (E) or the
combination (E+C) as 2nd or 3rd line therapy in patients with EGFR
wild-type (wt) NSCLC: a randomized phase 2 trial of the
ECOG-ACRIN Cancer Research Group (E1512).”
Dr.Joel Neal ,Stanford University Medical Center ,Palo Alto, CA
Oral Abstract Session: Lung Cancer – Non-Small Cell MetastaticSunday, May 31 , 8:00–11:00 a.m., N Hall B1 (talk from8:36-8:48 a.m. )
[Note: This is an NCI-CTEP study.]
-
Abstract 8007: “Phase II study of cabozantinib for patients with
advanced RET-rearranged lung cancers.”
Dr.Alexander Drilon ,Memorial Sloan Kettering Cancer Center ,New York, NY
Oral Abstract Session: Lung Cancer – Non-Small Cell MetastaticSunday, May 31 , 8:00–11:00 a.m., N Hall B1 (talk from 10:12–10:24 a.m.)
[Note: This is an Investigator-Sponsored Trial.]
Poster Discussions
-
Abstract 6012: “Final overall survival analysis of EXAM, an
international, double-blind, randomized, placebo-controlled phase III
trial of cabozantinib (Cabo) in medullary thyroid carcinoma (MTC)
patients with documented RECIST progression at baseline.”
Dr.Martin Schlumberger , Institut Gustave Roussy,Paris, France
Poster Session: Head and Neck Cancer
Poster presentedSaturday, May 30 , 1:15–4:45 p.m., S Hall A (Poster 335); discussed later in the day, from4:45-6:00 p.m. , in Room S 406.
-
Abstract 8021: “Response to crizotinib and cabozantinib in stage
IV lung adenocarcinoma patients with mutations that cause MET exon 14
skipping.”
Dr.Paul Paik ,Memorial Sloan Kettering Cancer Center ,New York, NY
Poster Session: Lung CancerMonday, June 1 , 8:00–11:30 a.m., S Hall A (Poster 343); discussed later in the day, from3:00-4:15 p.m. , in E Hall D2
[Note: This is an Investigator-Sponsored Trial.]
General Poster Presentations
-
Abstract 1080: “A Phase II study of cabozantinib for metastatic
triple-negative breast cancer (TNBC).”
Dr.Sara Tolaney ,The Dana Farber Cancer Institute ,Boston, MA
Poster Session: Breast Cancer – Triple-Negative/Cytotoxics/Local TherapySaturday, May 30 ,8:00 a.m. –11:30 a.m. , S Hall A (Poster 194)
[Note: This is an Investigator-Sponsored Trial.]
-
Abstract 5037: “Phase 1 study with expansion cohorts of
cabozantinib (C) + abiraterone (A) in metastatic castration resistant
prostate cancer.”
Dr.Christopher Sweeney ,The Dana Farber Cancer Institute ,Boston, MA
Poster Session: Genitourinary (Prostate) CancerSaturday, May 30 , 1:15–4:45 p.m., S Hall A (Poster 29)
[Note: This is an Investigator-Sponsored Trial.]
-
Abstract 8087: “Biomarker analysis of a phase II trial of
cabozantinib and erlotinib in patients (pts) with EGFR-mutant NSCLC
with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor
(TKI) resistance: A California Cancer Consortium Phase II Trial (NCI
9303).”
Dr.Karen Reckamp ,City of Hope Cancer Treatment Center ,Duarte, CA
Poster Session: Lung Cancer – Non-Small Cell MetastaticMonday, June 1 , 8:00–11:30 a.m., S Hall A (Poster 411)
[Note: This is an NCI-CTEP study.]
-
Abstract #TPS9087: “Randomized phase II study comparing the MET
inhibitor cabozantinib to temozolomide (TMZ) or dacarbazine (DTIC) in
ocular melanoma: A091201.”
Dr.Jason John Luke ,University of Chicago
Poster Session: Melanoma/Skin CancersMonday, June 1 , 1:15–4:45 p.m., S Hall A (Poster 326a)
[Note: This is an NCI-CTEP study and a Trials inProgress abstract.]
Cobimetinib will be the subject of six presentations from Genentech-sponsored trials of the compound. The full roster of cobimetinib presentations expected at the meeting (all times Central Daylight Time):
Oral Presentations
-
Abstract 9006: “Update of progression-free survival (PFS) and
correlative biomarker analysis from coBRIM: Phase III study of
cobimetinib (cobi) plus vemurafenib (vem) in advanced BRAF-mutated
melanoma.”
Dr.James M. G. Larkin ,The Royal Marsden NHS Foundation Trust
Oral Abstract Session: Melanoma/Skin CancersSaturday, May 30 , 1:15–4:15 p.m., Room E354b (talk from 3:15–3:27 p.m.)
Poster Presentations
-
Abstract 2573: “Population pharmacokinetics and dosing
implications for cobimetinib in patients with solid tumors.”
Kelong Han ,Genentech Inc. ,South San Francisco, CA
Poster Session: Developmental Therapeutics – Clinical Pharmacology and Experimental TherapeuticsSaturday, May 30 , 8:00–11:30 a.m., S Hall A (Poster 289)
-
Abstract 9020: “Extended follow-up results of phase 1B study
(BRIM7) of vemurafenib (VEM) with cobimetinib (COBI) in BRAF-mutant
melanoma.”
Dr.Anna Pavlick ,New York University Medical Center ,New York, NY
Poster Session: Melanoma/Skin CancersMonday, June 1 , 1:15–4:45 p.m., S Hall A (Poster 263)
-
Abstract 9021: “Quality-of-life (QOL) assessment in patients
(pts) with metastatic melanoma receiving vemurafenib (V) and
cobimetinib (C).”
Dr. Brigitte Dréno, Nantes University, Nantes,France
Poster Session: Melanoma/Skin CancersMonday, June 1 , 1:15 –4:45 p.m. , S Hall A (Poster 264)
-
Abstract 9033: “Clinical features of cobimetinib
(COBI)–associated serous retinopathy (SR) in BRAF-mutated melanoma
patients (pts) treated in the coBRIM study.”
Dr.Luis de la Cruz-Merino, Hospital Universitario Virgen Macarena,Seville, Spain
Poster Session: Melanoma/Skin CancersMonday, June 1 ,1:15 p.m. –4:45 p.m. , S Hall A (Poster 276)
-
Abstract TPS9088: “Phase 2 study of cobimetinib in combination
with vemurafenib in active melanoma brain metastases (coBRIM-B).”
Dr.Melissa K. Yee ,University of Pittsburgh Cancer Institute ,Pittsburgh, PA
Poster Session: Melanoma/Skin CancersMonday, June 1 ,1:15 p.m. –4:45 p.m. , S Hall A (Poster 326b)
[Note: This is a Trials inProgress abstract.]
About Cabozantinib
Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGFRs and RET. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.
COMETRIQ® (cabozantinib) is currently approved by the
Important Safety Information, including Boxed WARNINGS
WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE
- Serious and sometimes fatal gastrointestinal perforations and fistulas occur in COMETRIQ-treated patients.
- Severe and sometimes fatal hemorrhage occurs in COMETRIQ-treated patients.
- COMETRIQ treatment results in an increase in thrombotic events, such as heart attacks.
- Wound complications have been reported with COMETRIQ.
- COMETRIQ treatment results in an increase in hypertension.
- Osteonecrosis of the jaw has been observed in COMETRIQ-treated patients.
- Palmar-Plantar Erythrodysesthesia Syndrome (PPES) occurs in patients treated with COMETRIQ.
- The kidneys can be adversely affected by COMETRIQ. Proteinuria and nephrotic syndrome have been reported in patients receiving COMETRIQ.
- Reversible Posterior Leukoencephalopathy Syndrome has been observed with COMETRIQ.
- Avoid administration of COMETRIQ with agents that are strong CYP3A4 inducers or inhibitors.
- COMETRIQ is not recommended for use in patients with moderate or severe hepatic impairment.
- COMETRIQ can cause fetal harm when administered to a pregnant woman.
Adverse Reactions – The most commonly reported adverse drug reactions (≥25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most common laboratory abnormalities (≥25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia.
Please see full U.S. prescribing information, including Boxed WARNINGS,
at www.COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf.
Please refer to the full European Summary of Product Characteristics for
full
About the Cobimetinib and Vemurafenib Combination
Cobimetinib is a selective inhibitor that blocks the activity of MEK, a protein kinase that is part of a key pathway (the RAS-RAF-MEK-ERK pathway) that promotes cell division and survival. This pathway is frequently activated in human cancers including melanoma, where mutation of one of its components (BRAF) causes abnormal activation in about 50% of cases. Tumors with BRAF mutations may develop resistance and subsequently progress after treatment with a BRAF inhibitor. About 50% of patients with BRAF mutation positive melanoma experience a tumor response when treated with a BRAF inhibitor, however development of resistance and subsequent tumor progression limits treatment benefit. Clinical and preclinical analyses indicated that reactivation of the MEK-ERK pathway may underlie development of resistance to BRAF inhibitors in many progressing tumors, and that co-treatment with a BRAF and MEK inhibitor delays the emergence of resistance in the preclinical setting, providing the rationale for testing the combination of vemurafenib and cobimetinib in clinical trials. In addition to the combination with vemurafenib in melanoma, cobimetinib is also being investigated in combination with several investigational medicines, including an immunotherapy, in several tumor types, including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer and melanoma.
About
Source:
Exelixis, Inc.
Susan Hubbard, 650-837-8194
Investor Relations
and Corporate Communications
shubbard@exelixis.com