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Exelixis (EXEL) Reports Encouraging Data From Prostate Cancer Study
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Exelixis, Inc. (EXEL - Free Report) announced results from one of the cohorts in the phase Ib study of Cabometyx (cabozantinib) in combination with Roche’s (RHHBY - Free Report) Tecentriq in patients with locally advanced or metastatic solid tumors.
Cohort 6 included patients with metastatic castration-resistant prostate cancer (CRPC) who had been previously treated with Xtandi and/or Zytiga in this phase Ib COSMIC-021 study.The analysis included 132 patients. Among these, 101 had high-risk disease, defined as measurable visceral and/or extra-pelvic lymph node metastases.
Upon enrollment, patients had to have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1) per investigator assessment, which had progressed on prior novel hormonal therapy, and could have received prior docetaxel for hormone-sensitive disease.
Exelixis would pursue a regulatory filing in the United States for the high-risk patient population.
Results showed that the investigator-assessed ORR was 27%, including 2% complete responses (CR) and 25% partial responses (PR) in the high-risk population. The Blinded Independent Radiology Committee (BIRC)-assessed ORR was 18%, all of which were partial responses. The disease control rate (CR + PR + stable disease) was 88% and 84% per investigator and BIRC assessment, respectively.
These encouraging results from cohort 6 of this study suggest that this combination holds promise as a potential new treatment option in metastatic CRPC.
Exelixis intends to discuss the results with the FDA to determine the next steps toward a regulatory submission for the combination regimen for patients with high-risk metastatic CRPC, in continuation of prior regulatory interaction and feedback from the agency.
Meanwhile, the phase III study, CONTACT-02, initiated enrollment in June 2020 and is evaluating cabozantinib in combination with Tecentriq versus a second novel hormonal therapy in patients with metastatic CRPC who have been previously treated with one novel hormonal therapy.
Exelixis’ shares have gained 18% in the year so far against the industry’s decline of 4.9%.
Cabometyx (cabozantinib tablets) is approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma (HCC).
In January 2021, Exelixis obtained FDA approval for its supplemental new drug application (sNDA) for Cabometyx in combination with Bristol-Myers’ (BMY - Free Report) Opdivo as a first-line treatment of patients with advanced RCC. The approval of Cabometyx in combination with immuno-oncology drug, Opdivo, for advanced RCC should boost sales, going forward, given the market potential.
Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.91 in the past 60 days.
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Exelixis (EXEL) Reports Encouraging Data From Prostate Cancer Study
Exelixis, Inc. (EXEL - Free Report) announced results from one of the cohorts in the phase Ib study of Cabometyx (cabozantinib) in combination with Roche’s (RHHBY - Free Report) Tecentriq in patients with locally advanced or metastatic solid tumors.
Cohort 6 included patients with metastatic castration-resistant prostate cancer (CRPC) who had been previously treated with Xtandi and/or Zytiga in this phase Ib COSMIC-021 study.The analysis included 132 patients. Among these, 101 had high-risk disease, defined as measurable visceral and/or extra-pelvic lymph node metastases.
Upon enrollment, patients had to have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1) per investigator assessment, which had progressed on prior novel hormonal therapy, and could have received prior docetaxel for hormone-sensitive disease.
Exelixis would pursue a regulatory filing in the United States for the high-risk patient population.
Results showed that the investigator-assessed ORR was 27%, including 2% complete responses (CR) and 25% partial responses (PR) in the high-risk population. The Blinded Independent Radiology Committee (BIRC)-assessed ORR was 18%, all of which were partial responses. The disease control rate (CR + PR + stable disease) was 88% and 84% per investigator and BIRC assessment, respectively.
These encouraging results from cohort 6 of this study suggest that this combination holds promise as a potential new treatment option in metastatic CRPC.
Exelixis intends to discuss the results with the FDA to determine the next steps toward a regulatory submission for the combination regimen for patients with high-risk metastatic CRPC, in continuation of prior regulatory interaction and feedback from the agency.
Meanwhile, the phase III study, CONTACT-02, initiated enrollment in June 2020 and is evaluating cabozantinib in combination with Tecentriq versus a second novel hormonal therapy in patients with metastatic CRPC who have been previously treated with one novel hormonal therapy.
Exelixis’ shares have gained 18% in the year so far against the industry’s decline of 4.9%.
Cabometyx (cabozantinib tablets) is approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma (HCC).
In January 2021, Exelixis obtained FDA approval for its supplemental new drug application (sNDA) for Cabometyx in combination with Bristol-Myers’ (BMY - Free Report) Opdivo as a first-line treatment of patients with advanced RCC. The approval of Cabometyx in combination with immuno-oncology drug, Opdivo, for advanced RCC should boost sales, going forward, given the market potential.
Exelixis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Repligen Corporation (RGEN - Free Report) , which carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.91 in the past 60 days.
Bitcoin, Like the Internet Itself, Could Change Everything
Blockchain and cryptocurrency have sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.
Zacks has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
See 3 crypto-related stocks now >>