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.
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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.
- 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.