LUNG CANCER

Based on findings from the phase III IMpower133 study, a supplemental biologics license application (sBLA) for atezolizumab (Tecentriq) has been granted a priority review by the FDA for use in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer.

A look back at all the FDA news that happened in the month of November 2018, including several new approvals, priority reviews, a fast track designation, and an accelerated approval, across a variety of cancer types.

During a&nbsp;<em>Targeted Oncology&nbsp;</em>case-based peer perspectives program, Benjamin P. Levy, MD, discussed his clinical considerations for the management of non&ndash;small cell lung cancer.

Complex drug trials that use a single protocol to test either 1 agent against multiple cancers or multiple agents against 1 cancer can make drug testing faster, cheaper, and more informative, particularly when those trials use the data to constantly improve protocols.

The CheckMate-451 trial missed its primary endpoint of overall survival with the combination of&nbsp;nivolumab and ipilimumab as a maintenance therapy for patients with&nbsp;extensive-stage small cell lung cancer without disease progression following frontline platinum-based chemotherapy.

During a <em>Targeted Oncology </em>case-based peer perspectives program, Ryan Gentzler, MD, reviewed with other physicians his clinical considerations for the management of non&ndash;small cell lung cancer.

Using durvalumab&nbsp;(Imfinzi) combined with&nbsp;tremelimumab for the frontline treatment of patients with metastatic non&ndash;small cell lung cancer did not result in a&nbsp;statistically significant improvement in overall survival compared to standard chemotherapy, according to a press release from AstraZeneca.

Alexander E. Drilon, MD, discusses&nbsp;developing markers in the non&ndash;small cell lung cancer paradigm.

Alectinib (Alecensa) was found to be superior to&nbsp;crizotinib (Xalkori) as frontline therapy in Asian patients with&nbsp;untreated <em>ALK</em>-positive advanced non&ndash;small cell lung cancer (NSCLC), according to findings reported at the 2018 ESMO Congress.

Gilberto Lopes, MD,&nbsp;discusses findings from the phase III KEYNOTE-042 trial and ongoing developments with immunotherapy in NSCLC.

Lorlatinib (Lorbrena) has been granted an accelerated approval by the FDA for use in patients with&nbsp;<em>ALK</em>-positive metastatic non&ndash;small cell lung cancer who have progressed on 1 or more ALK tyrosine kinases inhibitors.

Based on findings from the phase III KEYNOTE-407 trial, pembrolizumab (Keytruda) has been approved by the FDA for use in combination with carboplatin and either paclitaxel or nab-paclitaxel (Abraxane) for the frontline treatment of patients with metastatic squamous non&ndash;small cell lung cancer.

I think one of the most important advancements in biomedical technology that has improved our understanding of the complexities of cancer is the ability to sequence the cancer genome for any individual patient, in a rapid and cost-effective manner, to help us make treatment decisions in the clinic.

Groundbreaking developments in cancer therapies can change lives, extending survival and sending patients who previously thought their chances were slim into remission. But these therapies come at a cost, and many patients reel at the prospect of heavy financial burdens. To help patients and programs meet the challenges of affording cancer treatments, community cancer centers are expanding the role of financial advocates in their organizations.

Results from the phase III IMpower130 trial demonstrated a statistically significant improvement in both progression-free survival and overall survival with a triplet regimen of&nbsp;atezolizumab, carboplatin, and nab-paclitaxel compared with chemotherapy alone in patients with previously untreated stage IV nonsquamous non&ndash;small cell lung cancer.

Three months have been added on by the FDA to the review period for the supplemental biologics license application for the frontline treatment combination of nivolumab plus low-dose ipilimumab for patients with advanced non&ndash;small cell lung cancer with tumor mutational burden &ge;10 mutations per megabase.

Ulrik Lassen, MD, PhD, discusses the updated response findings with larotrectinib in TRK+ cancers.

Among patients with advanced solid tumors associated with <em>NTRK</em> gene fusions, more than half had responses to&nbsp;the small-molecule inhibitor entrectinib, according to an integrated analysis of 3 clinical trials presented at the 2018 ESMO Annual Congress.

Larotrectinib induced an objective response rate of 80% in patients with advanced solid tumors who harbored&nbsp;<em>NTRK&nbsp;</em>gene fusions, according to results pooled from 3 small trials of the TRK inhibitor. Results were presented during the 2018 ESMO Congress.

Juergen Wolf, MD, medical director, Center for Integrated Oncology (CIO) at the University Hospital Cologne, discusses the phase II findings of the GEOMETRY mono-1 study in patients with MET exon 14-mutated advanced non-small cell lung cancer.

Patients with <em>EGFR</em>-mutant non&ndash;small cell lung cancer who had&nbsp;<em>MET</em> amplification and <em>EGFR</em> C797S mutations were most likely to have resistance to first-line treatment with&nbsp;osimertinib (Tagrisso),&nbsp;according to preliminary findings presented at the 2018 ESMO Congress.

Rising prescription drug prices continue to add to the burden of paying for quality healthcare. In an effort to confront such costs, the Centers for Medicare &amp; Medicaid Services has rescinded a prohibition on step therapy for Medicare Advantage plans. But some contend such a policy will reduce patient access to optimal medication.

Tumor mutational burden, also referred to as tumor mutational load, is a measure of the number of mutations in tumor tissue taken from a patient. Recently, several studies have been investigating the utility of TMB as a biomarker to predict response to therapy in patients with non&ndash;small cell lung cancer.

According to topline findings, the phase III CheckMate-331 trial of nivolumab monotherapy for patients with small cell lung cancer who relapsed following platinum-based chemotherapy failed to meet its primary endpoint of improved overall survival compared with the standard topotecan or amrubicin.

Justin F. Gainor, MD, assistant professor of medicine, Harvard Medical School, Massachusetts General Hospital, discusses the treatment landscape of oncogenic driver-positive NSCLC.