exelixis inc (EXEL) Key Developments
Exelixis, Inc. - Special Call
Jul 20 15
To discuss positive top-line results from the primary analysis of METEOR
Exelixis, Inc. Announces Executive Changes
Jul 16 15
Exelixis, Inc. announced the appointment of Christopher J. Senner as Executive Vice President and Chief Financial Officer. In this role, Mr. Senner will oversee the company’s global finance function, leveraging extensive experience
gained earlier in his career. Mr. Senner has nearly 25 years of experience in biopharmaceutical finance, including deep expertise in global financial operations and controls, strategic planning and analysis, supply chain finance and business development. He joins Exelixis after five years at Gilead Sciences, where he served as Vice President, Corporate Finance. Mr. Senner will succeed Deborah Burke, who has served as Senior Vice President and Chief Financial Officer
since September 2014.
Exelixis, Inc. Initiates Phase 1 Trial of Cabozantinib in Combination with Nivolumab Alone or Nivolumab Plus Ipilimumab
Jul 13 15
Exelixis, Inc. announced that the initiation of a phase 1 trial of cabozantinib in combination with nivolumab alone or in combination with nivolumab plus ipilimumab in patients with advanced/metastatic urothelial (bladder) and other genitourinary tumors. The primary endpoint of the trial is the determination of dose-limiting toxicities (DLT) and a recommended phase 2 dose (RP2D) for the combination of cabozantinib and nivolumab, and separately, for the combination of cabozantinib, nivolumab and ipilimumab, in patients with genitourinary solid tumors. Secondary endpoints include evaluating the activity of the two combinations by objective response rate, as well as progression-free survival (PFS) and overall survival (OS), in cohorts of patients with urothelial carcinoma of the bladder, urethra, ureter or renal pelvis. This open label, non-randomized phase 1 trial will enroll a maximum of 66 patients. The trial is divided into two parts: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase will enroll patients with metastatic genitourinary solid tumors including renal cell carcinoma, urothelial cancer and castration-resistant prostate cancer who have progressed following treatment with at least one standard therapy. Up to 24 patients will be treated with the combination of cabozantinib plus nivolumab (CaboNivo), and up to 18 patients will receive the combination of cabozantinib, nivolumab, and ipilimumab (CaboNivoIpi). The starting dose of cabozantinib will be 40 mg daily for each combination and can increase up to 60 mg daily. Depending upon the cohort, dose levels for nivolumab will range from 1 to 3 mg/kg administered on an every two or every three week schedule, and ipilimumab will be administered at a dose level of 1 mg/kg every three weeks for a maximum of 4 doses. Once the RP2Ds are determined for the combinations of CaboNivo and CaboNivoIpi, the trial will enroll expansion cohorts of up to 12 eligible patients for each combination, for up to 24 patients total in the expansion cohort. To be eligible for the expansion cohort, patients must have histologically confirmed metastatic, progressive urothelial cancer of the bladder, urethra, ureter, or renal pelvis. Patients in the expansion cohort will be evaluated for objective response rate, PFS and OS: all secondary endpoints of the trial.
Exelixis Announces Positive Results from Phase II Lung Cancer Trial
Jun 11 15
Exelixis Inc. has announced positive results from a two-stage Phase II investigator-sponsored trial evaluating cabozantinib in patients with advanced RET-rearranged lung cancers. Data were reported for the first stage, which enrolled 16 patients. The objective response rate (ORR) was 38%, with a median duration of response of 8 months. Although the trial is still accruing, it has already met its primary endpoint, exceeding the predefined targeted number of five objective responses. This single-institution, open-label phase II trial evaluates cabozantinib in patients with advanced RET-rearranged NSCLC, including the KIF5B-RET fusion, the most common rearrangement. Eligible patients must have stage IV lung cancer (with RET rearrangement confirmed by break apart fluorescence in situ hybridization and/or next generation sequencing), Karnofsky Performance Status greater than 70%, and measurable disease per RECIST 1.1. Patients receive 60 mg daily cabozantinib in 28-day cycles until disease progression or unacceptable toxicity. The trial is designed to enroll a maximum of 25 patients in two stages. The first stage of the trial, the subject of today's data presentation, enrolled 16 patients, and one partial response was required to expand the trial into its second stage that will enroll an additional nine patients. The primary endpoint of the trial is ORR, with five partial responses (PRs) required to meet the endpoint. Secondary endpoints include response rate at 12 weeks, progression-free survival (PFS), overall survival (OS), and toxicity. At the time of data cut-off, 20 patients had been treated and 18 were evaluable. Data were presented for the 16 patients enrolled in the first stage of the trial. The median age for patients in the first stage of the trial was 59 (range 38-80 years), and 62% (10/16) of these were female. All patients in the first stage had adenocarcinoma, the median number of prior lines of chemotherapy was 1, and 31% of patients had received greater then or equal to 2 lines of prior chemotherapy. Sixteen patients from the first stage of the trial were evaluable for tumor response. ORR, the primary endpoint of the trial, was 38%, with six confirmed PRs recorded. The median duration of response was 8 months (range 5.5-26 months) including one patient with a confirmed partial response who remained on treatment more than 25 months. One patient with a best response of
stable disease remained on cabozantinib treatment for more than 21 months. ORR at 12 weeks, a secondary endpoint, was 36%, with five confirmed PRs recorded among the 14 patients evaluable at 12 weeks. PFS and OS are secondary endpoints. The median PFS was 7 months (95% CI 5-NA). The median OS was 10 months (95% CI 8-NA) with a median follow-up of 24 months. Grade 3 adverse events deemed related to study drug by the investigators were thrombocytopenia (19%), increased lipase (13%), increased AST, hypophosphatemia, fatigue, oral mucositis, palmar plantar erthrodysesthesia, hypertension, and retroperitoneal hematoma (all 6%). Half of the patients (8/16) experienced one dose reduction to 40 mg during the course of therapy, with 19% (3/16) reducing to 20 mg daily. One patient discontinued therapy secondary to a grade 3 retroperitoneal hemorrhage, and there was one death unrelated to drug (grade 5 respiratory failure [post-thoracentesis]).
Exelixis, Inc. Announces Positive Results from Phase 2 Trial of Cabozantinib in Patients with EGFR Wild-Type Non-Small Cell Lung Cancer
May 31 15
Exelixis, Inc. announced positive results from a phase 2 clinical study evaluating cabozantinib as a treatment for EGFR wild-type non-small cell lung cancer (NSCLC). The trial, Study E1512, is a randomized phase 2 trial by the ECOG-ACRIN Cancer Research Group of cabozantinib and erlotinib, alone or in combination, as second- or third-line therapy in patients with metastatic EGFR wild-type NSCLC. Exelixis previously announced positive top-line results from this trial in November 2014. Data from the trial will be presented on May 31, 2015 during an oral presentation (Abstract #8003) at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held this week in Chicago, Illinois. Study chair Joel Neal, M.D., Ph.D., of ECOG-ACRIN's Thoracic Cancer Committee and an Assistant Professor of Medicine (Oncology) at Stanford University/Stanford Cancer Institute will present the results. Study E1512 met its primary endpoint, demonstrating significant increases in progression-free survival (PFS) for cabozantinib and the combination of cabozantinib plus erlotinib when individually compared to the erlotinib arm. The median PFS for the combination of cabozantinib and erlotinib was 4.7 months versus 1.9 months for erlotinib alone, a more than two-fold increase that corresponds to a 65% reduction in the risk of disease worsening (hazard ratio [HR]=0.35, 80% CI 0.23-0.52, p=0.0005). The median PFS for cabozantinib monotherapy was 4.2 months versus 1.9 months for erlotinib alone, a more than doubling that corresponds to a 62% reduction in the risk of disease worsening (HR=0.38, 80% CI 0.27-0.55, p=0.0004). Overall survival was a secondary endpoint of the trial. Median OS was 13.3 months for the combination of cabozantinib and erlotinib, and 9.2 months for cabozantinib alone, as compared to 4.1 months for erlotinib alone. These results correspond to a 56% reduction in the risk of death (HR=0.44, p=0.004) for the combination of cabozantinib plus erlotinib, and a 41% reduction in the risk of death (HR=0.59, p=0.03) for the cabozantinib monotherapy arm, respectively, when individually compared to the erlotinib arm. Objective response rate, another secondary endpoint, was 8% for the combination arm (2 partial responses [PR]), 14% (4 PRs) for the cabozantinib monotherapy arm, and 3% (1 PR) for the erlotinib arm. Stable disease as a best response was observed in 47% in the combination arm and 42% in the cabozantinib monotherapy arm, compared with 17% in the erlotinib arm. Study E1512 enrolled 125 patients with metastatic EGFR wild-type NSCLC who had received at one or two prior chemotherapy regimens; of these, 113 patients were evaluable for efficacy and 118 patients were evaluable for safety. Patients were randomized 1:1:1 to receive erlotinib (150 mg daily), cabozantinib (60 mg daily), or the combination of erlotinib plus cabozantinib (150 mg plus 40 mg daily). Median follow up was 12.6 months.