We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Exelixis (EXEL) Announces Results From Phase II HNSCC Study
Read MoreHide Full Article
Exelixis, Inc. (EXEL - Free Report) recently announced results from a phase II, investigator-sponsored trial of Cabometyx (cabozantinib) in combination with Merck’s (MRK - Free Report) Keytruda (pembrolizumab) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The trial met its primary endpoint of objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at 54%.
The overall clinical benefit rate was 91%. At a median follow-up of 10.6 months, the one-year progression-free survival rate was 54.0%, and the median progression-free survival was 14.6 months.
The one-year overall survival (OS) rate was 68.4%. For the 17 patients with a PD-L1 combined positive score (CPS) under 20, the one-year OS rate was 54.9%. For the 17 patients with a CPS score of 20 or more, the one-year OS rate was 83.6%.
Eligible patients had recurrent or metastatic HNSCC that was deemed inoperable, with measurable disease per RECIST version 1.1, a life expectancy of at least three months and an Eastern Cooperative Group Performance Status of 0 or 1.
The data will be presented at the 2022 American Society of Clinical Oncology Annual Meeting.
The data support the further development of a combination regimen of cabozantinib and an immune checkpoint inhibitor in patients with metastatic head and neck carcinoma.
Exelixis is an oncology-focused biotechnology company. Lead drug Cabometyx continues to perform well.
Please note that Cabometyx tablets are already approved for a number of indications — the treatment of patients with advanced renal cell carcinoma (RCC), for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and for patients with advanced RCC as a first-line treatment in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab). It has also been approved for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible.
Exelixis is working on expanding the drug’s label further, and the successful development should boost sales.
Bristol-Myers’ Opdivo is one of its leading revenue generators and is approved for various oncology indications.
Exelixis’ shares have lost 0.5% in the year so far compared with the industry’s decline of 23.8%.
Image Source: Zacks Investment Research
Exelixis’ first-quarter results were mixed, with earnings beating expectations but sales missing the mark. The approval of Cabometyx combined with the immuno-oncology drug Opdivo for advanced RCC boosted sales. However, competition is stiff in this space and capturing additional market share might become tough.
We note that Merck’s Keytruda, in combination with Inlyta, is also indicated for the first-line treatment of patients with advanced RCC.
Merck’s Keytruda, an anti-PD-1 therapy, is approved for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.
Image: Bigstock
Exelixis (EXEL) Announces Results From Phase II HNSCC Study
Exelixis, Inc. (EXEL - Free Report) recently announced results from a phase II, investigator-sponsored trial of Cabometyx (cabozantinib) in combination with Merck’s (MRK - Free Report) Keytruda (pembrolizumab) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The trial met its primary endpoint of objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at 54%.
The overall clinical benefit rate was 91%. At a median follow-up of 10.6 months, the one-year progression-free survival rate was 54.0%, and the median progression-free survival was 14.6 months.
The one-year overall survival (OS) rate was 68.4%. For the 17 patients with a PD-L1 combined positive score (CPS) under 20, the one-year OS rate was 54.9%. For the 17 patients with a CPS score of 20 or more, the one-year OS rate was 83.6%.
Eligible patients had recurrent or metastatic HNSCC that was deemed inoperable, with measurable disease per RECIST version 1.1, a life expectancy of at least three months and an Eastern Cooperative Group Performance Status of 0 or 1.
The data will be presented at the 2022 American Society of Clinical Oncology Annual Meeting.
The data support the further development of a combination regimen of cabozantinib and an immune checkpoint inhibitor in patients with metastatic head and neck carcinoma.
Exelixis is an oncology-focused biotechnology company. Lead drug Cabometyx continues to perform well.
Please note that Cabometyx tablets are already approved for a number of indications — the treatment of patients with advanced renal cell carcinoma (RCC), for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and for patients with advanced RCC as a first-line treatment in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab). It has also been approved for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible.
Exelixis is working on expanding the drug’s label further, and the successful development should boost sales.
Bristol-Myers’ Opdivo is one of its leading revenue generators and is approved for various oncology indications.
Exelixis’ shares have lost 0.5% in the year so far compared with the industry’s decline of 23.8%.
Image Source: Zacks Investment Research
Exelixis’ first-quarter results were mixed, with earnings beating expectations but sales missing the mark. The approval of Cabometyx combined with the immuno-oncology drug Opdivo for advanced RCC boosted sales. However, competition is stiff in this space and capturing additional market share might become tough.
We note that Merck’s Keytruda, in combination with Inlyta, is also indicated for the first-line treatment of patients with advanced RCC.
Merck’s Keytruda, an anti-PD-1 therapy, is approved for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.
Exelixis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.