Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non–Small-Cell Lung Cancer
Targeted therapy in NSCLC, FCS was part of this trial.
Importance of NGS testing cannot be overemphasized. Besides poziotinib (which has very reasonable clinical benefit), anti-HER2 combination therapy may be of value in this patient population. Studies are ongoing. Poziotinib-related rash and diarrhea are manageable with proper understanding and interventions.
Insertion mutations in Erb-b2 receptor tyrosine kinase 2 gene (ERBB2 or HER2) exon 20 occur in 2%-5% of non–small-cell lung cancers (NSCLCs) and function as an oncogenic driver. Poziotinib, a tyrosine kinase inhibitor, was evaluated in previously treated patients with NSCLC with HER2 exon 20 insertions.
ZENITH20, a multicenter, multicohort, open-label phase II study, evaluated poziotinib in patients with advanced or metastatic NSCLC. In cohort 2, patients received poziotinib (16 mg) once daily. The primary end point was objective response rate evaluated by independent review committee (RECIST v1.1); secondary outcome measures were disease control rate, duration of response, progression-free survival, and safety and tolerability. Quality of life was assessed.
Between October 2017 and March 2021, 90 patients with a median of two prior lines of therapy (range, 1-6) were treated. With a median follow-up of 9.0 months, objective response rate was 27.8% (95% CI, 18.9 to 38.2); 25 of 90 patients achieved a partial response. Disease control rate was 70.0% (95% CI, 59.4 to 79.2). Most patients (74%) had tumor reduction (median reduction 22%). Median progression-free survival was 5.5 months (95% CI, 3.9 to 5.8); median duration of response was 5.1 months (95% CI, 4.2 to 5.5). Clinical benefit was seen regardless of lines and types of prior therapy, presence of central nervous system metastasis, and types of HER2 mutations. Grade 3 or higher treatment-related adverse events included rash (48.9%), diarrhea (25.6%), and stomatitis (24.4%). Most patients had poziotinib dose reductions (76.7%), with median relative dose intensity of 71.5%. Permanent treatment discontinuation because of treatment-related adverse events occurred in 13.3% of patients.
Poziotinib demonstrates antitumor activity in previously treated patients with HER2 exon 20 insertion NSCLC.
Targeted therapy in NSCLC, FCS was part of this trial.
FCS medical oncologist and hematologist Lowell L. Hart, MD, FACP was first-author a study with FCS co-authors President and Managing Physician Lucio N. Gordan, MD, Director of Pharmacy Operations Kristen Boykin, Senior Vice President & Data Officer Trevor Heritage, PhD, and (Retired) Vice President of Pharmacy Services Ray Bailey BPharm, RPh, that evaluated ES-SCLC patients with chemotherapy-induced myelosuppression over a seven-year period, from January 2013 through December 2020. Within this cohort, 98% of the patients experienced at least one myelosuppressive episode following chemotherapy treatment, leading to the need for supportive care, creating additional costs in health care management and time lost in treatment for ES-SCLC.
Suddenly met-NSCLC is a crowded space. This study did not conclude that T+D+CT was better than D+CT, the findings showed that D+CT was better than CT alone. The addition of T to D+CT improved the PFS and OS trend but I don’t think this was a homerun result. There was not a significant OS benefit and further follow-up will declare these results. Also an improved outcomes were not seen in the non-squamous population. The pembrolizumab studies have 5+ years of follow-up and an improvement in PFS and OS across NSCLC subtypes.
Interesting study which the demonstrates the importance of prescriptive approach to detect NSCLC. Hopefully, in the future ctDNA may enhance or replace LDCT ability to detect patients with stage I/II disease.
This is a potential practice-changing study. Future data on overall-survival (OS) will be important to confirm results. Patient selection will also evolve over time especially in real-world practice. I presume more patients with stage II/III will get neoadjuvant therapy as opposed to a patient with a small lung nodule (stage I) taken to surgery, unless if there is significant OS for early stage patients as well.
FCS Hematology Oncology Review creates a platform for our physician network to observe the most recent articles and studies available in the oncology and hematology world. By sharing these articles we are building our wealth of knowledge of new observations and treatments as they come available.
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