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.
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 home run result. There was no significant OS benefit, and further follow-up will declare these results. Also, 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.
The open-label, phase III POSEIDON study evaluated tremelimumab plus durvalumab and chemotherapy (T + D + CT) and durvalumab plus chemotherapy (D + CT) versus chemotherapy alone (CT) in first-line metastatic non–small-cell lung cancer (mNSCLC).
Patients (n = 1,013) with EGFR/ALK wild-type mNSCLC were randomly assigned (1:1:1) to tremelimumab 75 mg plus durvalumab 1,500 mg and platinum-based chemotherapy for up to four 21-day cycles, followed by durvalumab once every 4 weeks until progression and one additional tremelimumab dose; durvalumab plus chemotherapy for up to four 21-day cycles, followed by durvalumab once every 4 weeks until progression; or chemotherapy for up to six 21-day cycles (with or without maintenance pemetrexed; all arms). Primary end points were progression-free survival (PFS) and overall survival (OS) for D + CT versus CT. Key alpha-controlled secondary end points were PFS and OS for T + D + CT versus CT.
PFS was significantly improved with D + CT versus CT (hazard ratio [HR], 0.74; 95% CI, 0.62 to 0.89; P = .0009; median, 5.5 v 4.8 months); a trend for improved OS did not reach statistical significance (HR, 0.86; 95% CI, 0.72 to 1.02; P = .0758; median, 13.3 v 11.7 months; 24-month OS, 29.6% v 22.1%). PFS (HR, 0.72; 95% CI, 0.60 to 0.86; P = .0003; median, 6.2 v 4.8 months) and OS (HR, 0.77; 95% CI, 0.65 to 0.92; P = .0030; median, 14.0 v 11.7 months; 24-month OS, 32.9% v 22.1%) were significantly improved with T + D + CT versus CT. Treatment-related adverse events were maximum grade 3/4 in 51.8%, 44.6%, and 44.4% of patients receiving T + D + CT, D + CT, and CT, respectively; 15.5%, 14.1%, and 9.9%, respectively, discontinued treatment because of treatment-related adverse events.
D + CT significantly improved PFS versus CT. A limited course of tremelimumab added to durvalumab and chemotherapy significantly improved OS and PFS versus CT, without meaningful additional tolerability burden, representing a potential new option in first-line mNSCLC.
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.
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.
Lots of progress to be accomplished here. Increased standardization of care, quality metrics based on guideline-adherence and best practices remain critical to progress.
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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