EGFR+ Lung Cancer

The FDA has granted approval to injectable pemetrexed for the treatment of patients with locally advanced or metastatic nonsquamous non–small cell lung cancer and for those with malignant pleural mesothelioma.

A subgroup analysis of Korean patients from the pooled data of two global phase II trials, AURA extension and AURA2, has found that osimertinib is as safe and effective in this subgroup of patients with pretreated EGFR-mutated advanced non-small cell lung cancer with T790M positive status as it was in the parent trials.

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

Afatinib demonstrated clinical activity against uncommon and compound <em>EGFR</em> mutations in patients with EGFR tyrosine kinase inhibitor-naive non&ndash;small cell lung cancer, a patient population for which limited data exist on the efficacy of treatment with EGFR- tyrosine kinase inhibitors, according to Yang et al.

The addition of the dinutuximab injection to irinotecan did not improve overall survival in patients with relapsed/refractory small cell lung cancer, failing to meet the primary end point of the phase III DISTINCT trial, according to top-line results announced in a press release from United Therapeutics, developer of dinutuximab.

In a phase II trial, the combination of lenvantinib and pembrolizumab demonstrated a manageable safety profile and encouraging antitumor activity in patients with selected advanced solid tumors.&nbsp;The decision to combine the agents was based on preclinical data, which suggested that VEGF and FGF signaling may enhance the therapeutic efficacy of lenvatinib.

The New Drug Application for selpercatinib was granted FDA Priority Review for the treatment of patients with advanced&nbsp;RET&nbsp;fusion&ndash;positive non&ndash;small cell lung cancer,&nbsp;RET-mutant medullary thyroid cancer, and&nbsp;RET&nbsp;fusion&ndash;positive thyroid cancer, based on data from the phase I/II LIBRETTO-001 trial, Eli Lilly and Company announced in a press release.

Bemcentinib in combination with pembrolizumab demonstrated clinical efficacy in the stage 1 portion of a phase II trial, which evaluated the combination in patients with non&ndash;small cell lung cancer who progressed on prior immune checkpoint inhibition, meeting the primary end point of the study.

The FDA has granted a Fast Track Designation to the immune-gene therapy Oncoprex in combination with the EGFR inhibitor osimertinib for the treatment of patients with&nbsp;<em>EGFR</em>-mutant non&ndash;small cell lung cancer who have progressed after treatment with osimertinib alone.

The Investigational New Drug Application for the novel EGFR tyrosine kinase inhibitor BBT-176 was cleared by the FDA for treatment of&nbsp;EGFR C797S&ndash;mutant non&ndash;small cell lung cancer, according to a press release from Bridge Biotherapeutics, Inc, developer of BBT-176.

For patients with non&ndash;small cell lung cancer, having a body mass index &ge;30 at baseline could be independently associated with an improvement in overall survival with atezolizumab and could be considered a stratification factor in immune checkpoint inhibitor trials, according to a study published in JAMA Oncology.

In an interview with&nbsp;Targeted Oncology, Steven H. Kirtland, MD, FCCP, discussed the different factors that play a role in the decline of lung cancer mortality over the last few years. He highlighted how these advancements will continue to impact the survival of patients with lung cancer and his thoughts on the evolving landscape.

Integrating a geriatric assessment into the care of older adults who are receiving cancer treatment in communi&shy;ty oncology practices improves patient and caregiver satisfaction and encourages commu&shy;nication about aging-related concerns, accord&shy;ing to results of a clinical trial that enrolled 541 patients with advanced cancer.

In an interview with&nbsp;Targeted Oncology,&nbsp;Pasi A. J&auml;nne, MD, PhD,&nbsp;discussed the current treatment landscape for patients with&nbsp;EGFR-mutant lung cancer, as well as some therapies that currently are under both preclinical and clinical investigation at the Dana-Farber Cancer Institute. He shared advice for community oncologists treating this patient population.

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;

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.

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.

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 an interview with&nbsp;Targeted Oncology, Brennan J. Decker, MD, PhD, discussed a real-life scenario of a patient with lung cancer who harbored both an&nbsp;EGFR&nbsp;and&nbsp;BRAF&nbsp;mutation. He highlighted the key takeaways of this case, which he presented at the 2019 Association for Molecular Pathology Annual Meeting and Expo.

With the inevitability of resistance to first- and second-generation EGFR tyrosine kinase inhibitors in patients with EGFR-mutant non&ndash;small cell lung cancer, novel options like lazertinib, an irreversible, third-generation, mutant-selective, EGFR TKI are being explored. Lazertinib has shown promise for the treatment of this patient population, according to a phase I/II dose-escalation study published in The Lancet Oncology.