Updated Lenvatinib Data Expected at European Cancer Congress

Abstracts highlighting the latest clinical data on lenvatinib are expected at the 2015 European Cancer Congress in Vienna, Austria, according to an Eisai Co, Ltd news release. Four abstract presentations on lenvatinib are scheduled to occur at the meeting.¹

Oral presentation

One of the oral presentations, which will be presented on September 26, 2015, (abstract 2805) will feature an updated analysis on overall survival (OS) benefit from the pivotal phase III SELECT study on radioiodine-refractory differentiated thyroid cancer (DTC), which led to the FDA approval of the drug for locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC.^2,3

The randomized, double-blind, placebo-controlled study⁴included 392 patients and was conducted from August 2011 through October 2012. Crossover from placebo to the lenvatinib was allowed upon disease progression. Enrolled patients were required to have at least one measurable lesion without iodine uptake on any radioactive iodine (RAI) scan, at least one measurable lesion that had progressed within 12 months after RAI therapy, or cumulative activity of iodine 131 that was >600 millicurie. Radiologic evidence of progression within the previous 13 months was also required for enrollment. Twenty-five percent of patients on lenvatinib and 20.6% patients on placebo received one prior TKI. Lenvatinib was administered to patients on the treatment arm at a dosage of 24 mg.

The drug demonstrated significant progression-free survival, according to the previously presented phase III data (18.3 vs 3.6 months, HR, 0.21; 99% CI, 0.14-0.31;P<.001). Benefit was also seen in patients who were treated with VEGFR-targeting kinase inhibitors before the trial.

Common toxicities included hypertension (any grade, 69.3%; grade &ge;3, 42.9%), diarrhea (any grade, 59.4%; grade &ge;3, 41.8%), fatigue or asthenia (any grade, 59%; grade &ge;3, 27.5%), decreased weight (any grade, 46.4 %; grade &ge;3, 9.2%), nausea (any grade, 41%; grade &ge;3, 13.7%), and proteinuria (any grade, 32.2%; grade &ge;3, 10.0%).

Six deaths (2.3%) that occurred on the lenvatinib arm were deemed treatment related. The direct causes of these deaths included hemorrhagic stroke, pulmonary embolism, and deterioration of physical health, one in each case; no specific causes of the remaining deaths were reported. Treatment discontinuation, dose reduction, and treatment interruption occurred in 14.2%, 82.4%, and 67.8% patients in the lenvatinib group, respectively. The mean lenvatinib dose was 17.2 mg per day.

Poster presentations

A poster presentation (abstract 432) will also appear highlighting a correlative analysis of serum biomarkers and clinical outcomes in a phase II study in patients with metastatic renal cell carcinoma (RCC).¹Lenvatinib was granted a breakthrough therapy designation by the FDA in July 2015 as a potential treatment for patients with advanced RCC who have received a VEGF-targeted therapy.⁵

Other poster presentations include: The influence of time to objective response on lenvatinib clinical outcomes in the phase III SELECT trial (abstract 2862); and Defining¹³¹I-refractory differentiated thyroid cancer: efficacy and safety of lenvatinib by¹³¹I-refractory criteria in the SELECT trial 9 (abstract 2864).¹

Lenvatinib is approved and available as a treatment for DTC in the United States, Japan, and Europe.¹

References

1. Eisai news release. Eisai to present latest clinical data on Lenvima (lenvatinib) and Halavan (eribulin) at European Cancer Congress.http://www.eisai.com/news/news201562.html. Accessed September 14, 2015.
2. Scott LJ. Lenvatinib: first global approval. Drugs. 2015;75(5):553-560.
3. Lenvima prescribing information.www.accessdata.fda.gov/drugsatfda_docs/label/2015/206947s000lbl.pdf. Woodcliff Lake, NJ, 2015. Accessed September 14, 2015.
4. Schlumberger M, Tahara M, Wirth LJ, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015;372(7):621- 630.
5. Eisai news release. Eisai&rsquo;s in-house developed novel anticancer agent Lenvima receives breakthrough therapy designation from the U.S. FDA for renal cell carcinoma.http://www.eisai.com/news/news201552.html. Accessed September 14, 2015.