ASCO Late-Breakers for Monday June 3, 2019

Late-breaking studies featured today at this morning’s press briefing as the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting continues included the phase 3 OSLO-COMET trial, the phase 2 EV-201 trial, and a study suggesting clinical trial participation of patients with lung cancer could be increased by revising eligibility criteria.

Laparoscopic and open resection equally effective for colorectal liver metastases (LBA3516)

Results of the first study to compare laparoscopic versus open resection for colorectal cancer liver metastases were presented. This Norwegian study randomly assigned 280 patients to either minimally invasive laparoscopic surgery (n=133) or open surgery (n=147) using liver parenchyma-sparing techniques.

Laparoscopic surgery was cost-effective and was associated with improved health-related quality of life, fewer post-operative complications (19% vs 31%), and shorter hospital stays (2 vs 4 days), compared with open surgery.

At a median follow-up of 45 months, there were no statistically significant differences between laparoscopic and open surgery for median survival (80 vs 81 months), median recurrence-free survival (19 vs 16 months), 5-year survival (57% vs 56%), 5-year recurrence-free survival (29% vs 31%), rate of complete tumor removal, or amount of tissue removed beyond the observable tumor. Patients were able to have recurrent tumors surgically removed if necessary.

ASCO Expert Nancy Baxter, MD, said, “This is an excellent example of high-quality evidence that will guide patient care. The essential thing is everybody who has a potentially curable disease should receive surgery,” regardless of which technique is used.

Enfortumab vedotin continues to show promise in previously treated advanced urothelial cancer (LBA4505)

Enfortumab vedotin (EV) is an antibody-drug conjugate targeting Nectin-4, a protein found in most urothelial cancers. EV-201 is a single arm, open-label, phase 2 trial enrolling individuals with locally advanced or metastatic urothelial cancer who had received platinum-based chemotherapy plus checkpoint inhibitors (cohort 1) or checkpoint inhibitors only (no platinum chemotherapy; cohort 2) (NCT03219333). Preliminary results were reported today for cohort 1. Cohort 2 is ongoing.

Of 125 patients treated in cohort 1, 44% had a confirmed objective response, of which 12% were complete responses. Median overall survival was 11.7 months (95% CI, 9.1-not reached), median progression-free survival was 5.8 months, (95% CI, 4.9-7.5), and median duration of response was 7.6 months (95% CI, 0.95-11.3).

Of those whose cancer had not previously responded to checkpoint inhibitor treatment, 41% had a response to EV; 38% of patients with liver metastases also had a response. EV was well-tolerated. The most common treatment-related adverse events were fatigue (50%), alopecia (49%), and decreased appetite (44%).

Planned trials of EV include EV-301, a randomized, phase 3 trial versus standard of care in previously treated, advanced urothelial cancer after platinum chemotherapy (NCT03474107), and EV-103, a trial of EV in combination with pembrolizumab and/or chemotherapy (NCT032884545).

EV is associated with durable responses in a heavily pretreated population. “When you see activity there you know there is something real going on. To what extent will require the randomized trial that is ongoing. From an unmet need perspective there is no question that this is a real drug with benefit for patients,” said ASCO Expert Robert Dreicer, MD.

Broader trial enrollment criteria could double eligible patients with advanced NCSLC (LBA108)

Clinical trial enrollment in the US is abysmally low. ASCO and Friends of Cancer Research propose expanding clinical trial eligibility to accelerate accrual, allow more patients to participate in clinical research, and enroll trial populations more representative of patient populations.

This retrospective electronic health record (EHR) review looked at the potential effect of broadened clinical trial inclusion criteria on enrollment in clinical trials of adults with advanced non-small cell lung cancer (NSCLC). Adults with advanced NSCLC who had ≥2 visits to an oncologist and ≥1 dose of a systemic treatment after diagnoses were identified from ASCO’s CancerLinQ database records from 2011 to 2018.

The suggested broadened inclusion criteria analyzed here included allowing individuals with brain metastases, another previous or concurrent cancer diagnosis, or a creatinine clearance as low as 30 mL/min. Traditional criteria exclude brain metastases, prior or concurrent cancer diagnosis, and creatinine clearance <60 mL/min.

Of 10,500 individuals with advanced NSCLC who were identified, 47.7% (5,005 people) would not meet standard trial eligibility criteria. The adoption of expanded criteria would exclude only 1.5% (154 people), expanding the potential trial population by 4,851 individuals. The adoption of expanded criteria therefore nearly double the potential NSCLC trial population compared with traditional criteria.

Finally, also at the press briefing, Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence introduced Project Facilitate, a pilot program to provide health-care professionals with continuous support throughout the expanded access (EA) process for oncology drugs. Ellen Sigal, PhD, introduced the Reagan-Udall EA Navigator designed to increase patient awareness of trial sponsor policies and clinicaltrials.gov listings.

by Lynne Lederman, PhD

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