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Is Exelixis' (EXEL) Growth Story Likely to Continue?

Exelixis EXEL, an oncology-focused company, maintains momentum on the back of the solid performance of its lead drug Cabometyx amid stiff competition

Cabometyx is a tablet formulation of cabozantinib approved for treating patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.

In particular, the approval of Cabometyx for patients with advanced RCC as a first-line treatment in combination with Bristol Myers’ BMY Opdivo (nivolumab) has fueled sales of the drug.

Bristol-Myers’ Opdivo is one of the leading revenue generators of the company and is approved for various oncology indications.

Cabometyx is also approved for previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). Cabometyx generated sales of $641.97 million in the first half of 2022, up 29%.

The capsule formulation of cabozantinib is approved as Cometriq for progressive, metastatic medullary thyroid cancer (MTC).

In addition, the pipeline progress has been impressive as the company strives to expand Cabometyx’s label and concurrently develop its portfolio beyond lead drug Cabometyx.

Other candidates in Exelixis’ pipeline include XL092, a next-generation oral tyrosine kinase inhibitor (TKI); XB002, an antibody drug conjugate (ADC) that targets tissue factor (TF); XL102, a potent, selective and orally bioavailable covalent inhibitor of cyclin-dependent kinase 7 (CDK7); and XL114, a novel anti-cancer compound that inhibits the CARD11-BCL10-MALT1 (CBM) complex.

Earlier this month, the company announced results from the dose-escalation stage of STELLAR-001, an ongoing phase Ib trial evaluating XL092 as a single-agent and in combination with Tecentriq (atezolizumab) in patients with locally advanced or metastatic solid tumors. 

Both single-agent XL092 and XL092 in combination with atezolizumab demonstrated encouraging efficacy and safety in a heavily pretreated patient population. XL092 demonstrated preliminary clinical activity similar to that observed with cabozantinib in phase I across a range of solid tumors and dose levels, with a manageable safety profile.  Based on the results, the 100 mg dose of XL092 was selected for the expansion phase, which is ongoing in a number of solid tumor types.

Exelixis has also initiated the dose-escalation stage of the first-in-human phase I trial of XL114 as a monotherapy in patients with NHL who have received prior standard therapies.

Meanwhile, the company is also forming strategic collaborations to strengthen its pipeline. In July, Exelixis entered into an exclusive license agreement with Ryvu Therapeutics to develop novel STING agonist-based targeted cancer therapies.

In June, Exelixis and BioInvent entered into an option and license agreement focused on identifying and developing novel antibodies for use as oncology therapeutics. The collaboration is intended to expand Exelixis’ portfolio of antibody-based therapies.

The successful development of additional drugs will broaden its portfolio and reduce its dependence on the lead drug Cabometyx.

Competition is stiff in the RCC space, and capturing additional market share might become tough for Exelixis.

Merck’s MRK Keytruda, in combination with Pfizer’s PFE 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.

Pfizer’s Inlyta has shown strong performance, driven by continued adoption in the United States and Europe. PFE’s older drug Sutent is also approved for advanced RCC.



 


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