EGFR+ Lung Cancer

A 62-Year-Old Male With Stage III Non-Small Cell Lung Cancer

To help clinicians cope with an increasing number of geriatric patients with cancer, the Association of Community Cancer Centers is addressing this problem with a 2-pronged approach that focuses on the delivery of care and diagnostic assessment.

The FDA has granted Priority Review to the New Drug Application for brigatinib as first-line treatment for patients with ALK-positive metastatic non–small cell lung cancer as detected by an FDA-approved test, Takeda Pharmaceutical Company announced in a press release.

Preliminary results from a safety and tolerability phase I/II study signal promise for ADXS-503 alone and in combination with pembrolizumab as treatment of patients with metastatic squamous and non-squamous non–small cell lung cancer, Advaxis, Inc, announced in a press release. Findings were presented during the International Association for the Study of Lung Cancer 2020 Targeted Therapies of Lung Cancer Meeting, February 19-22, 2020, in Santa Monica, California.

As one of the main challenges faced by cli­nicians who treat non small cell lung cancer, drug resistance continues to thwart efforts to mitigate disease progression. This is especially true for the class of drugs called tyrosine kinase inhibitors, which inhibit adenosine triphosphate at the binding site of tyrosine kinase.

A 64-Year-Old Male with Untreated Stage IV EGFR-Mutated NSCLC

The FDA has granted Priority Review to the supplemental Biologic License Application for atezolizumab as first-line treatment of patients with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing. 

The FDA has granted Priority Review to the New Drug Application for lurbinectedin, which is being considered for accelerated approval as a treatment of patients with small cell lung cancer who have progressed after prior platinum-containing therapy.

Pepinemab plus avelumab has shown initial signals of antitumor activity and is well tolerated in patients with advanced non–small cell lung cancer, according to an interim analysis of the CLASSICAL-Lung phase Ib/II clinical trial presented at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium in Orlando, Florida.

The FDA granted Priority Review to the New Drug Application for capmatinib, an investigational selective MET inhibitor, which will be used as treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping-mutated non–small cell lung cancer, Incyte announced in a press release.

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.