The OncFive: Top Oncology Articles of the Week of 1/5

Welcome to OncLive®’s OncFive! Every week, we will compile the top 5 stories in oncology, ranging from pivotal regulatory decisions to news updates and expert interviews spanning tumor types.

Here’s what you may have missed this week:

Sunvozertinib Under FDA Priority Review for NSCLC With EGFR Exon 20 Insertion Mutations

The regulatory agency granted priority review to a new drug application seeking approval of sunvozertinib (DZD9008) for use in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations that have progressed on or following platinum-based chemotherapy. The submission is based on data from the phase 2 WU-KONG1 Part B trial (NCT03974022) which showed that when the agent was given at a once-daily dose of 300 mg (n = 107) it elicited a best overall response rate (ORR) of 53.3% (97.5% CI, 42.0%-64.3%) and a confirmed ORR of 44.9% (97.5% CI, 34.0%-56.1%).

Amivantamab Plus Lazertinib Improves OS in EGFR-Mutant Advanced NSCLC

The final prespecified secondary end point of the phase 3 MARIPOSA study (NCT04487080) has been met, as frontline amivantamab-vmjw (Rybrevant) combined with lazertinib (Lazcluze) significantly improved overall survival vs osimertinib (Tagrisso) monotherapy in patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or L858R substitution mutations. “Seeing this increase in OS in a trial with mature data is powerful and reaffirms that first-line treatment with [amivantamab] and [lazertinib] can lead to better patient outcomes,” Stephen Liu, MD, of Georgetown’s Lombardi Comprehensive Cancer Center, stated in a news release.

FDA Issues Draft Guidance for Accelerated Approval Confirmatory Clinical Trials

The Oncology Center of Excellence has issued a draft guidance document describing the regulatory agency’s interpretation of when a confirmatory clinical trial for an accelerated approval is underway. The finalized resource will comprise policies for implementing the requirement of a confirmatory trial including factors that will be considered when determining whether such a trial is underway before an accelerated approval action.

Iparomlimab/Tuvonralimab Plus Chemo ± Bevacizumab Yields Responses in Recurrent/Metastatic Cervical Cancer

Updated findings from the phase 2 DUBHE-C-204 trial (NCT05179317) indicated that iparomlimab with tuvonralimab (QL1706) and chemotherapy plus or minus bevacizumab (Avastin) elicited confirmed ORR of 75.9% (95% CI, 62.8%-86.1%) in the overall efficacy-evaluable population of patients with recurrent or metastatic cervical cancer (n = 58) at a median follow-up of 27.0 months (range, 1.4-35.3). The confirmed ORRs with iparomlimab/tuvonralimab and chemotherapy with (cohort 2; n = 30) or without (cohort 1; n = 28) bevacizumab were 76.7% (95% CI, 57.7%-90.1%) and 75.0% (95% CI, 55.1%-89.3%).

Subcutaneous Isatuximab Plus Pd Meets Coprimary End Points, Proves Noninferior to IV Administration in R/R Multiple Myeloma

The randomized, open-label, phase 3 IRAKLIA trial (NCT05405166) met its coprimary end points, as fixed-dose subcutaneous isatuximab-irfc (Sarclisa) plus pomalidomide (Pomalyst) plus dexamethasone (Pd) proved to be noninferior with regard to ORR and observed concentration before dosing (Ctrough) at steady state vs intravenous isatuximab plus Pd in patients with relapsed or refractory multiple myeloma. Important secondary end points like very good partial response rate, incidence of infusion reactions and Ctrough at cycle 2 were also met. Full results from the study will be shared at an upcoming conference.