Exelixis, Inc. EXEL announced an amendment to the protocol for the phase Ib trial of cabozantinib combined with Roche Holdings’ RHHBY Tecentriq in patients with locally advanced or metastatic solid tumors.
Per the amendment, there will be four new expansion cohorts to the trial. The cohorts will include include patients with NSCLC and CRPC, in addition to previously included patients with renal cell carcinoma (RCC) and urothelial carcinoma (UC). The primary objective in the expansion stage of this trial is to determine the objective response rate in each cohort.
The cohorts will now include the following patients with advanced non-squamous NSCLC without a defined tumor genetic alteration (EGFR, ALK, ROS1, or BRAF) who have not received prior therapy with immune checkpoint inhibitors, patients with NSCLC without a defined tumor genetic alteration who have progressed following treatment with immune checkpoint inhibitor, patients with UC who have progressed following treatment with an immune checkpoint inhibitor, patients with CRPC who have previously received enzalutamide and/or abiraterone acetate and experienced radiographic disease progression in soft tissue.
The multicentre phase Ib open label study is divided into two parts — a dose-escalation phase and an expansion cohort phase.
The main objective is to calculate the optimal dose and schedule of daily oral administration of cabozantinib. The trial will begin enrolment in the eight expansion cohorts once the recommended dose and schedule are determined (anticipated to occur in the first half of 2018).
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Exelixis’ stock have rallied a massive 108.2% in the last one year compared with the industry’s gain of 3.8%.
In April 2016, a tablet formulation of cabozantinib, Cabometyx, was approved in the United States for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
Cabometyx delivered strong sales in the first nine months of 2017, underlying the increasing demand for the drug. New patient market share in the second-line plus setting increased to 38%.
The recent FDA approval of Cabometyx for the treatment of previously untreated advanced RCC should further boost demand. The drug demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus the current standard of care, Pfizer Inc.’s PFE Sutent.
Apart from Roche, Exelixis also inked agreement with Bristol-Myers Squibb BMY to jointly develop cabozantinib in collaboration with immunotherapy agents. Exelixis collaborated with Bristol-Myers to evaluate cabozantinib in combination with Opdivo alone or along with Yervoy in a phase III trial in first-line RCC, and potentially in other tumor types including (HCC and bladder cancer). The companies have initiated a phase III trial, CheckMate 9ER in July 2017 to evaluate Opdivo in combination with Cabometyx or Opdivo and Yervoy in combination with Cabometyx versus Sutent in patients with previously untreated, advanced or metastatic RCC.
While competition might stiffen a bit in 2018 as the the FDA accepted Bristol-Myers’ supplemental Biologics License Application. The application includes priority review of Opdivo plus Yervoy to treat intermediate- and poor-risk patients with advanced RCC with an action date of Apr 16, 2018. We expect Exelixis to ride high on the performance of Cabometyx in 2018.
Zacks Rank
Exelixis flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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