Lawrence E. Feldman, MD, medical oncologist, professor of Medicine, the University of Illinois Cancer Center, discusses the phase 3 LEAP-006 trial (NCT03829319) evaluating lenvatinib (Lenvima) and pembrolizumab (Keytruda) plus chemotherapy in non–small cell lung cancer (NSCLC).

The global, randomized, double-blind, placebo-controlled, 2-part trial is evaluating pembrolizumab plus platinum-based chemotherapy, with or without lenvatinib, in patients with previously untreated metastatic nonsquamous NSCLC. Part 1 featured the safety run-in portion of the trial, and the ongoing part 2 is randomized, double-blind portion of the reaserch.

Data from part 1 of LEAP-006 showed that lenvatinib and pembrolizumab plus chemotherapy was well tolerated, Feldman says. Positive safety data were reported, with less than 3 dose-limiting toxicities occurring in each of the 2 arms of the study, Feldman explains.

The findings on safety and tolerability led to the opening of enrollment part 2 of the study in October 2021. With the part 2 primary end points of progression-free survival and overall survival, investigators will look for some of the antitumor activity observed in part 1 of the trial, Feldman concludes.

Videos

Lawrence E. Feldman, MD, discusses the phase 3 LEAP-006 trial evaluating lenvatinib and pembrolizumab plus chemotherapy in non–small cell lung cancer.


Dr. Feldman on Lenvatinib and Pembrolizumab Plus Chemotherapy in NSCLC

Lawrence E. Feldman, MD, professor of clinical medicine, University of Illinois Cancer Center, discusses the use of prophylactic cranial irradiation (PCI) in patients with limited-stage (LS) and extensive-stage (ES) small cell lung cancer (SCLC).

For decades, PCI was performed in LS-SCLC based on a meta-analysis that demonstrated improved overall survival (OS) and decreased occurrence of brain metastases, says Feldman. Conversely, in ES-SCLC, a randomized phase III trial (UMIN000001755) from Japan showed no OS benefit with PCI comparedwith observation. 

As such, patients with ES-SCLC are typically monitored closely with regular MRI scans every 3 months in the first year, and every 6 months in the second year. 

Although PCI is used more commonly in LS-SCLC, it may not be necessary in all patients. Rather, some patients could be observed and spared some of the neurocognitive toxicities associated with PCI, concludes Feldman.

Lawrence E. Feldman, MD, discusses utilizing prophylactic cranial irradiation in limited-stage and extensive-stage small cell lung cancer. 
 

Dr. Feldman on Prophylactic Cranial Irradiation in SCLC

Lawrence E. Feldman, MD, medical oncologist, University of Illinois Cancer Center, discusses the future of durvalumab (Imfinzi) and tremelimumab in non—small cell lung cancer (NSCLC).

In 2016, promising activity was published in 

 on the combination of durvalumab and tremelimumab, explains Feldman. The phase Ib trial enrolled 102 patients with locally advanced or metastatic NSCLC who had not been exposed to immunotherapy. There was no limit on prior lines of therapy. Of 63 evaluable patients, 11 had objective responses and 18 achieved disease control by week 24.

In July 2017, the combination of durvalumab and tremelimumab failed to improve progression-free survival (PFS) in patients with stage IV metastatic NSCLC versus standard platinum-based chemotherapy in the MYSTIC trial. Though the trial failed to meet the primary endpoint of improving PFS versus standard of care in patients with ≥ 25% PD-L1 expression, the trial was also designed to assess overall survival, results of which are anticipated later this year, says Feldman.

Lawrence E. Feldman, MD, medical oncologist, University of Illinois Cancer Center, discusses the future of durvalumab (Imfinzi) and tremelimumab in non–small cell lung cancer (NSCLC).

Dr. Feldman on the Future of Durvalumab and Tremilimumab in NSCLC

Lawrence E. Feldman, MD, medical oncologist, University of Illinois Cancer Center, discusses durvalumab (Imfinzi) for patients with lung cancer.

Durvalumab is a very exciting agent given the recently announced data that indicates an improvement in overall survival, especially in stage III patients with lung cancer.

This data shows that consolidation therapy after chemoradiation with durvalumab is a very promising combination. As a result, Feldman says he is looking forward to using durvalumab in his own practice.

Lawrence E. Feldman, MD

Articles

Dr. Feldman on Lenvatinib and Pembrolizumab Plus Chemotherapy in NSCLC

Dr. Feldman on Prophylactic Cranial Irradiation in SCLC

Dr. Feldman on the Future of Durvalumab and Tremilimumab in NSCLC

Dr. Feldman on Durvalumab for Patients With Lung Cancer