Top news of the week in oncology and cancer drug development.
Lenvatinib Succeeds in Phase III Frontline HCC Trial
Frontline treatment with lenvatinib (Lenvima) was shown to be noninferior to standard therapy with sorafenib (Nexavar) in patients with unresectable hepatocellular carcinoma (HCC), according to Eisai, the developer of the multikinase inhibitor. In a phase III trial, known as Study 304, overall survival (OS) outcomes with lenvatinib were noninferior to OS results with sorafenib, meeting the study’s primary endpoint.
The findings also demonstrated statistically significant improvements with lenvatinib for secondary endpoints, including progression-free survival, time to progression, and objective response rate (ORR). Eisai reported that it intends to present the full data at an upcoming scientific meeting and will also discuss the findings with the FDA and global regulatory authorities. Results from a phase II study of lenvatinib in patients with advanced HCC were published last year in the Journal of Gastroenterology.
The study enrolled 46 patients between July 2010 and June 2011 at locations across Japan and Korea. Patients were not eligible for surgery or local therapy. The ORR was 37%, comprising all partial responses (n = 17). Nineteen patients (41%) had stable disease and the disease control rate was 78%. The median OS was 18.7 months (95% CI, 12.7-25.1).
Maintenance Lenalidomide Nears European Approval in Post-ASCT Myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of lenalidomide (Revlimid) as a maintenance therapy following autologous stem cell transplant (ASCT) for patients with newly diagnosed multiple myeloma, according to Celgene, the manufacturer of the treatment. The application is based on data from 2 phase III trials, CALGB 100104 and IFM 2005-02.
Both studies were unblinded after post-ASCT maintenance lenalidomide significantly reduced the risk of disease progression or death in patients with multiple myeloma. The positive opinion from the CHMP will now be reviewed by the European Commission. A final approval decision for use in the European Union is expected in about 2 months. A meta-analysis of data pooled from CALGB 100104, IFM 2005-02, and a third randomized phase III trial, GIMEMA-RVMM-PI-209, was presented at the 2016 ASCO Annual Meeting.
The findings showed that maintenance lenalidomide following frontline treatment with high-dose melphalan and ASCT reduced the risk of death by 26% versus placebo or no maintenance in patients with multiple myeloma. The 7-year overall survival rate was 62% with maintenance lenalidomide versus 50% in patients who did not receive the therapy.
Pembrolizumab Provides Durable Activity in Mucosal Melanoma
Pembrolizumab (Keytruda) demonstrated durable activity in 3 clinical trials in previously treated patients with a rare subtype of melanoma, according to a presentation during the 2017 European Cancer Congress in Amsterdam. Among the patients with advanced melanoma treated with pembrolizumab in the KEYNOTE-001, KEYNOTE-002, and KEYNOTE-006 studies, patients with mucosal melanoma (n = 84) had a median duration of response of 27.6 months.
The objective response rate (ORR) in the patients with mucosal melanoma was 19% (95% CI, 12-29) with 16 patients responding, and the disease control rate (DCR) was 31% (95% CI, 22-42). The median progression-free survival (PFS) rate was 2.8 months (95% CI, 2.7-2.8) and the median overall survival (OS) rate was 11.3 months (95% CI, 7.7-16.6). Of the patients previously treated with ipilimumab, the ORR was 15% (95% CI, 7-31) with 5 patients responding and the DCR was 27% (95% CI, 15-44). In the 3 trials, patients with nonmucosal melanoma had an ORR of 33% (95% CI, 30-35) and the DCR was 47% (95% CI, 44-49). The median PFS was 4.2 months (95% CI, 3.6-5.5) and the median OS was 23.5 months (95% CI, 21.1-26.8).
2017 Cancer Survivorship Symposium
The 2017 Cancer Survivorship Symposium was held this week in San Diego, California, providing information about survivorship issues that arise throughout the cancer care continuum. One study shared patient surveys suggesting that the treatment benefits of brentuximab vedotin (Adcetris) outweigh the risk of peripheral neuropathy associated with the antibody-drug conjugate.
Another study showed that patients diagnosed with thyroid cancer before the age of 40 were more likely to be at an increased risk of late effects such as hypertension, heart disease, and osteoporosis, than patients diagnosed at age 40 or older.
A third trial found that an online coping curriculum can improve fatigue and depression in breast cancer survivors.
ASCO Addresses Trump Travel Ban
Leaders from the American Society of Clinical Oncology (ASCO) said that the Trump administration’s restrictions on travel from 7 Middle Eastern countries will limit the exchange of ideas. In a press release, ASCO said that more than 10,000 people from around the world participate in its scientific meetings, the largest of which is held annually in Chicago in late May to early June.
“Millions of cancer survivors are alive today because of the progress made possible by scientific collaboration. Progress against this disease will falter if the close-knit global community of cancer care providers is divided by policies that bar members of certain nationalities form entering the US to conduct research, care for people with cancer, or participate in scientific and medical conferences.” ASCO called for an end to "unjustified barriers to scientific exchange and medical education," and said the organization was working with public officials so they understand the executive order's impact.