CRLX101 Combined With Bevacizumab May Be Effective for Patients With mRCC

CRLX101 should be examined further as an adjunctive therapy to bevacizumab for patients with metastatic renal cell carcinoma (mRCC), according to a study published in the Annals of Oncology.¹

Twenty-two patients with mRCC were enrolled in this phase 1/2a trial, and were treated every 2 weeks with bevacizumab (10 mg/kg) combined with escalating doses of CRLX101 (12-15 mg/m²). Treatment was given until disease progression or unacceptable toxicity; 5 patients (23%) achieved partial responses, 12 (55%) achieved progression-free survival for more than 4 months. Dose-limiting toxicities did not occur.

The researchers concluded that CRLX101, an investigational, nanoparticle drug, which has shown synergistic potential when combined with anti-angiogenic agents such as bevacizumab in a preclinical setting, should be tested further. A randomized, phase 2 clinical trial of this drug combination for patients with mRCC is ongoing.

Cases of adverse events relating to CRLX101 included grade 3 or higher non-infectious cystitis (5), fatigue (3), anemia (2), and diarrhea (2). These were assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Reference

1. Keefe SM, Hoffman-Censits J, Cohen RB, Mamtani R, Heitjan D, Eliasof S, et al. Efficacy of the nanoparticle–drug conjugate CRLX101 in combination with bevacizumab in metastatic renal cell carcinoma: results of an investigator-initiated phase I–IIa clinical trial [published online ahead of print June 8, 2016]. Ann Oncol. doi: 10.1093/annonc/mdw188.