Biomarker-Driven Lung Cancer

Alterations of the NRG1 gene that are present at low rates in certain solid tumors have emerged as potentially actionable oncogenic drivers, with targeted therapies making their way to early clinical studies and into some basket trials.

The FDA has granted priority review to the Biologics License Application for nivolumab in combination with ipilimumab for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations, according to a press release from the Bristol-Myers Squibb Company.<br /> &nbsp;

To support the commercialization of the blood-based companion diagnostic test Guardant360 companion diagnostic for AMG 510, Guardant Health, Inc, will collaborate with Amgen, developer of AMG 510, and pursue an FDA Pre-Market Approval as a companion diagnostic for AMG 510 in patients with metastatic non&ndash;small cell lung cancer with a&nbsp;KRAS&nbsp;G12C mutation, according to a press release.

The present and future benefits of telehealth in oncology can be observed through Tahoe For&shy;est Cancer Center and its affiliation with the UC Davis Cancer Center, use of other remote clinics, and participation in virtual tumor boards. Even though there are roadblocks to telehealth reaching more locations and more patients, the potential benefit warrants the time needed to get over those hurdles.

Pralsetinib&nbsp; a highly-selected RET inhibitor, achieved a favorable overall response rate with prolonged durability in patients with RET fusion&ndash;positive non&ndash;small cell lung cancer who were previously treated with platinum-based chemotherapy, according to top-line results from the phase I/II ARROW trial, announced the Blueprint Medicines Corporation in a press release.

The combination of pembrolizumab and chemotherapy improved progression-free survival in patients with small cell lung cancer compared with chemotherapy alone, meeting 1 of the primary end points of the phase III KEYNOTE-604 study, according to a press release from pembrolizumab developer, Merck. Compared with a chemotherapy regimen of either etoposide plus cisplatin or cisplatin alone, the progression-free survival mprovement with pembrolizumab was significant.

The FDA granted approval to countless treatments across cancer types throughout 2019 until the end of the year, with a final approval on December 31^st&nbsp;for the first BRCA targeted therapy in pancreatic cancer. Following the excitement for a new year of further advances,&nbsp;Targeted Oncology&nbsp;followers on Twitter shared their thoughts on some of the most impactful FDA approvals in 2019.

Justin F. Gainor, MD, discusses the latest advancements with immune checkpoint inhibitors for the treatment of patients with non&mdash;small cell lung cancer.

In December 2019, the FDA approved a number of new treatments in lung cancer, pancreatic cancer, urothelial carcinoma, breast cancer, and prostate cancer. A&nbsp;tissue complete assay was also approved by the FDA for use in a clinical trial evaluating pembrolizumab.

Osimertinib demonstrated a manageable toxicity profile and encouraging activity in patients with non&ndash;small cell lung cancer who harbor an uncommon EGFR mutation, according to results from a phase II clinical trial conducted in Korea.

Selpercatinib will be compared with the standard of care in the first ever phase III clinical trial in patients with advanced or metastatic treatment-na&iuml;ve&nbsp;<em>RET</em>&nbsp;fusion-positive non&ndash;small cell lung cancer, according to a press release from Eli Lilly and Company.

A new drug application has been filed for accelerated approval with the FDA for lurbinectedin in patients with small cell lung cancer who have progressed after prior platinum-containing therapy, according to the manufacturer, PharmaMar.1 The filing was based on results from a phase II basket trial, presented at the 2019 ASCO Annual Meeting.

Pembrolizumab showed improvements in overall survival, progression-free survival, and objective response rate compared with pemetrexed or paclitaxel chemotherapy in patients with metastatic nonsquamous non&ndash;small cell lung cancer whose tumors are PD-L1&ndash;positive, regardless of their&nbsp;KRAS&nbsp;mutational status.

In a&nbsp;Targeted Oncology&nbsp;case-based peer perspectives live discussion, Nathan A. Pennell, MD, PhD, associate professor of the Department of Medicine at Case Western Reserve University and a medical oncologist at Taussig Cancer Center and the Cleveland Clinic Cancer Center discussed treatment options for EGFR-mutant non&ndash;small cell lung cancer, based on the case of a real patient.<br /> &nbsp;

Cancer has historically been divided between localized and metastatic disease. The underlying principle, derived from the Halsted theory of cancer progression, is that once cancer has spread to other sites, it is a systemic disease. Heroic efforts to remove or ablate all evidence of visible cancer thus would expose patients to toxicity without a chance for benefit.

The FDA granted an Investigational Device Exemption approval to the Personal Genome Diagnostics Inc. elio^TM&nbsp;tissue complete assay for use in a Merck trial evaluating pembrolizumab combinations in non&ndash;small cell lung cancer, according to a press release from PGDx, developer of the assay.

Improving Overall Survival In Extensive Stage Small Cell Lung Cancer

The FDA has approved the combination of atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy for the treatment of patients with metastatic nonsquamous non&ndash;small cell lung cancer, according to a press release from Genentech USA, Inc.<br /> &nbsp;

Andreas Rimner, MD, gives an overview of his presentation titled, &ldquo;Crossing the PACIFIC,&rdquo; which he presented at the 2019 New York Lung Cancers Symposium. He evaluates some potential next steps for durvalumab (Imfinzi) following the practice-changing results from the PACIFIC trial.

A supplemental Biologics License Application for durvalumab has been accepted by the FDA, and the drug has been granted priority review for the treatment of previously untreated extensive-stage small cell lung cancer, according to a press release from AstraZeneca.

In patients whose solid<strong> </strong>tumors harbor a mutation in <em>KRAS </em>G12C, therapy with MRTX849 has produced promising responses and acceptable toxicity across 3 tumors types, according to data presented at the 2019 American Association for Cancer Research&ndash;National Cancer Institute&ndash;European Organization for Research and Treatment of Cancer International Conference on Molecular Targets and Cancer Therapeutics.

Tumor mutational burden has generated interest as a potential biomarker of response to immunotherapy and has already been examined in the context of several lung cancer trials to gauge its utility.

In an interview with Targeted Oncology, Chul Kim, MD, MPH, discussed the results from the phase I/II trial evaluating the combination of an EGFR TKI and Src inhibitor in&nbsp;<em>EGFR</em>-mutant NSCLC. He also highlighted other important advances in the treatment of lung cancer, including the evolving role of circulating tumor DNA to detect disease progression.

The FDA has accepted a Biologics License Application (BLA) for SB8, a biosimilar candidate to reference bevacizumab that was submitted by Samsung Bioepis in September 2019, according to a press release from the company.

Patients with untreated advanced EGFR-mutant non&ndash;small cell lung cancer showed an improvement in progression-free survival with the combination of gefitinib, a TKI that targets EGFR, with carboplatin plus pemetrexed compared with gefitinib alone, according to the results of the NEJ009 study.