EGFR+ Lung Cancer

A look back at all the FDA news that happened in the month of December 2018, including several new approvals, an accelerated approval, and a priority review.

To assist clinicians in the day-to-day management of their patients, the Society for Immunotherapy of Cancer has developed its first guidelines to help direct immune checkpoint inhibitor treatment of NSCLC.

Adding aggressive, local radiation or surgery to frontline systemic therapy in patients with stage IV NSCLC whose disease has spread to a limited number of sites resulted in improved overall survival, according to findings presented by Daniel Gomez, MD, and colleagues at the 60th Annual Meeting of the American Society for Radiation Oncology in San Antonio, Texas.

Diwakar Davar, MBBS, MSc, discusses how data from the phase I trial of TSR-022, an anti-TIM-3 monoclonal antibody, and TSR-042, an anti-PD-1 agent, impact the treatment of patients with both melanoma and lung cancer.

The review period for&nbsp;a supplemental biologics license application for first-line treatment with pembrolizumab monotherapy for the treatment of patients with locally advanced or metastatic nonsquamous or squamous non&ndash;small cell lung cancer with PD-L1 expression (tumor proportion score) of &ge;1% and no&nbsp;<em>EGFR&nbsp;</em>or&nbsp;<em>ALK&nbsp;</em>genomic tumor aberrations has been extended by the FDA, according to a press release by Merck,&nbsp;the manufacturer of pembrolizumab.

Several oncology experts discuss the FDA approvals they found most significant in 2018.

Precision medicine has produced some dramatic successes in patients with advanced cancer. With developments in molecular profiling, targeted therapies are being applied to multiple tumors, most notably in advanced melanoma, NSCLC, and several types of leukemia. Alison Schram, MD, and David M. Hyman, MD, point out the challenges in determining the proportion of patients who will benefit from receiving targeted therapies.

Acquired resistance to tyrosine kinase inhibitors targeting <em>EGFR</em> mutations in patients with non&ndash;small cell lung cancer are leading to next-generation therapies equipped to circumvent the mutations that arise from initial treatment.&nbsp;A review of these mechanisms, and the latest agents being developed to address them, shows that the pipeline holds promise for the future.

The phase III TAHOE trial evaluating rovalpituzumab tesirine as a second-line treatment for&nbsp;patients with advanced small cell lung cancer has been put on hold, based on a recommendation from an&nbsp;Independent Data Monitoring Committee, according to AbbVie, the developer of the investigational antibody-drug conjugate.<br /> &nbsp;

Mark G. Kris, MD, discusses what is most important in treating patients with lung cancer today.

Atezolizumab (Tecentriq) has been approved by the FDA&nbsp;for use in combination with bevacizumab, carboplatin, and paclitaxel as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer. This indication excludes patients with <em>EGFR</em>/<em>ALK</em> aberrations.

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&nbsp;for use in combination with carboplatin and etoposide for the frontline treatment of&nbsp;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.

Vassiliki A. Papadimitrakopoulou, MD, Jay and Lori Eisenberg Distinguished Professor of Medicine and section chief of thoracic medical oncology in the department of thoracic/head and neck medical oncology at The University of Texas MD Anderson Cancer Center, discusses the data that were presented at the World Conference on Lung Cancer earlier this year for the IMpower 132 trial comparing the combination of carboplatin/cisplatin plus atezolizumab (Tecentriq) to standard chemotherapy in patients with 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.

James L. Wade III, MD, FACP, FASCO, discusses the importance of clinical trials in the community.

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.

Thomas A. Gallo, MS, MDA, president of the Association of Community Cancer Centers, discusses his mission as president to &ldquo;reflect, renew, and reignite&rdquo; in order to create a more resilient oncology team for the community.

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.