Exelixis Announced Results from its CABOMETYX® Combination with Roche’s TECENTRIQ®
News announced by Exelixis (EXEL) about encouraging results from the combination of its product cabozantinib (CABOMETYX®) with Roche’s product atezolizumab (TECENTRIQ®) on metastatic castration-resistant prostate cancer (CRPC). The results emanated from the COSMIC-021 phase 1b trial.
The data will be presented on Thursday, February 13th during Poster Session A: Prostate Cancer at 11:30 a.m. – 1:00 p.m. PT and 5:30 – 6:30 p.m. PT at the 2020 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU 2020) being held in San Francisco, California from February 13 – 15, 2020.
To enroll in the trial, the patients had to have measurable disease per Response Evaluation Criteria in Solid Tumors, had progressed on prior novel hormone therapy.
Forty-four patients were included in this interim analysis.
The median follow up was 12.6 months.
The objective response rate (ORR) per RECIST v. 1.1, the trial’s primary endpoint, was 32%, including two complete responses and 12 partial responses.
Disease control rate was 80%.
The firm’s announcement states that among the 36 patients with high-risk clinical features, including visceral metastases and/or extra-pelvic lymph node metastases the results demonstrate the following:
The ORR was 33%.
The Median duration of response was 8.3 months.
Among 12 patients who had an objective response and at least one post-baseline prostate-specific antigen (PSA) evaluation, 67% had a PSA decline of at least 50%.
Explaining the results, Neeraj Agarwal, M.D., Professor, Huntsman Cancer Center, University of Utah, and an investigator of the trial said, “Given the poor prognosis for men with metastatic castration-resistant prostate cancer, measurable visceral disease and/or extra-pelvic lymph node metastases who have progressed on novel hormone therapies, we are excited to observe clinically meaningful activity with the combination of cabozantinib and atezolizumab in this COSMIC-021 cohort. Emerging data suggest a tolerable safety profile and encouraging efficacy for this combination that may hold promise for these patients with limited treatment options, potentially providing patients with more time before the need for treatment with chemotherapy. We look forward to additional results as the trial progresses.”
The median treatment duration was 6.3 months (range 1 to 18 months). No new safety signals were identified in this combination cohort. Treatment-related grade 3/4 adverse events (AEs) occurring in ≥5% of patients were fatigue (7%), diarrhea (7%) and hyponatremia (7%). One treatment-related grade 5 AE of dehydration was reported in a 90-year-old patient. The discontinuation rate of study treatment for adverse events unrelated to disease progression was low at 7%.
On January 7, 2020 the metastatic CRPC cohort 6 of COSMIC-021 had been expanded to enroll up to 130 patients.
Based on regulatory feedback from the FDA, and if supported by the clinical data from the recently expanded existing cohort and added metastatic CRPC cohorts, Exelixis intends to file with the FDA for accelerated approval in a metastatic CRPC indication as early as 2021.
Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, stated, “We’re happy to share these encouraging results from the metastatic CRPC cohort from COSMIC-021, our first trial evaluating the combination of cabozantinib and atezolizumab. We look forward to receiving data from the most recent expansion of this CRPC cohort while we are also preparing for the initiation of phase 3 pivotal trial in this indication. We are excited about the emerging data in metastatic CRPC and elsewhere and the potential of combining cabozantinib with immunotherapies in this and other difficult-to-treat tumor types.”
Read more information at ClinicalTrials.gov.
About the COSMIC-021 Study
This trial is a multicenter, phase 1b, open-label study that is divided into two parts: a dose-escalation phase and an expansion cohort phase.
The dose-escalation phase: This phase was designed to enroll patients either with advanced renal cell carcinoma (RCC) with or without prior systemic therapy or with inoperable, locally advanced, metastatic or recurrent urothelial carcinoma (UC), (including renal, pelvis, ureter, urinary bladder and urethra) after prior platinum-based therapy. Ultimately, all 12 patients enrolled in this stage of the trial were patients with advanced RCC. The dose-escalation phase of the study determined the optimal dose of cabozantinib to be 40 mg daily when given in combination with atezolizumab (1200 mg infusion once every 3 weeks).
The results were presented at the European Society for Medical Oncology 2018 Congress.
The Expansion Phase
This Phase is enrolling 24 cohorts in 12 tumor types: RCC, UC, non-small cell lung cancer (NSCLC), CRPC, hepatocellular carcinoma (HCC), triple-negative breast cancer, epithelial ovarian cancer, endometrial cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, head and neck cancer, and differentiated thyroid cancer. Up to 1,720 patients may enroll in this phase of the trial: each expansion cohort will initially enroll approximately 30 patients, and up to 10 cohorts may further expand enrollment resulting in up to 1,000 patients across such potential additional expansion cohorts.
Four of the cohorts are exploratory — three are enrolling approximately 30 patients each with advanced UC, CRPC or NSCLC to be treated with cabozantinib as a single-agent, and one is enrolling approximately 10 patients with advanced CRPC to be treated with single-agent atezolizumab. Exploratory cohorts have the option to be expanded up to 80 patients (cabozantinib) and 30 patients (atezolizumab) total.
Exelixis is the study sponsor of COSMIC-021. Ipsen has opted in to participate in the trial and is contributing to the funding for this study under the terms of the companies’ collaboration agreement. Roche is providing atezolizumab for the trial.
According to the American Cancer Society, approximately 192,000 new cases of prostate cancer will be diagnosed and 33,000 people will die from the disease this year. Prostate cancer that has spread beyond the prostate and does not respond to androgen-suppression therapies — a common treatment for prostate cancer — is known as metastatic CRPC. Researchers estimate that in 2020, 43,000 people with prostate cancer will progress to metastatic CRPC, which has a median survival of fewer than two years.
About Exelixis CABOMETYX® (cabozantinib)
In the U.S., Exelixis CABOMETYX tablets are approved for advanced RCC and for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. CABOMETYX tablets have been approved in the European Union and other countries worldwide.
In 2016 Exelixis granted Ipsen exclusive rights to commercialize and further clinical develop cabozantinib outside of the United States and Japan.
In 2017 Exelixis granted exclusive rights to Takeda Pharmaceutical for the commercialization and further clinical development of cabozantinib for all future indications in Japan.
We like and followed up on Exelixis because we recognized of the fact that cabozantinib will be capable of treating many cancers that resist existing drugs as monotherapy and in combination with other products, especially immunotherapy products.
Also attracting us is the firm’s capability of recognizing the best usage of cabozantinib and of doing its due diligence towards further developing it for more cancers that are known to resist other treatments, using it either in monotherapy or sby electing the right product to combine it with.
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