The OncFive: Top Oncology News and Trends for the Week of 10/13

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:

FDA Approves Zolbetuximab Plus Chemo for CLDN18.2+ Gastric or GEJ Adenocarcinoma

On October 18, 2024, the FDA approved zolbetuximab-clzb (Vyloy) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are Claudin 18.2 positive, as determined by an FDA-approved test.

The approval was supported by data from the phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials. The addition of zolbetuximab to mFOLFOX6 improved progression-free survival (PFS) vs placebo plus mFOLFOX6 in SPOTLIGHT (HR, 0.751; 95% CI, 0.598-0.942; 1-sided P = .0066). In GLOW, zolbetuximab plus CAPOX also improved PFS vs placebo plus CAPOX (HR, 0.687; 95% CI, 0.544-0.866; 1-sided P = .0007).

Gilead to Withdraw Urothelial Cancer Indication for Sacituzumab Govitecan in Urothelial Cancer

Gilead announced that it intends to voluntarily withdraw the United States indication of sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with pretreated, locally advanced or metastatic urothelial cancer.

After the FDA granted accelerated approval to sacituzumab govitecan in April 2021 for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor, the confirmatory phase 3 TROPiCS-04 trial (NCT04527991) failed to meet its primary end point of OS for the antibody-drug conjugate vs investigator’s choice of single-agent chemotherapy in patients with locally advanced or metastatic urothelial cancer who received prior treatment with platinum-containing chemotherapy and anti–PD-1/PD-L1 therapy.

The company said the decision will not impact any other indications for sacituzumab govitecan in the United States or abroad.

FDA Approves Optune Lua for Metastatic NSCLC After Platinum-Based Chemotherapy

On October 15, 2024, the FDA approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adult patients with metastatic non–small cell lung cancer whose disease has progressed on or after a platinum-based regimen.

The approval of tumor-treating fields was based on data from the phase 3 LUNAR trial (NCT02973789), where patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel achieved a median overall survival of 13.2 months (95% CI, 10.3-15.5) vs 9.9 months (95% CI, 8.2-12.2) for those given a PD-1/PD-L1 inhibitor or docetaxel alone (P = .04).

Updated RAMP 201 Data to Support NDA Submission for Avutometinib/Defactinib Combo in Recurrent KRAS+ Ovarian Cancer

Verastem Oncology announced that it intends to complete a new drug application (NDA) in October 2024 seeking FDA approval for the combination of avutometinib (VS-6766) and defactinib (VS-6063) for the treatment of adult patients with recurrent low-grade serous ovarian cancer harboring KRAS mutations who have received at least 1 prior line of systemic therapy.

The NDA will include updated data from the phase 2 RAMP 201 trial (NCT04625270), which were presented this week at the 2024 International Gynecologic Cancer Society Annual Meeting. Findings showed that all evaluable patients with low-grade serous ovarian cancer treated during the study (n = 109) experienced a confirmed overall response rate (ORR) of 31% (95% CI, 23%-41%). In patients harboring KRAS mutations (n = 57), the confirmed ORR was 44% (95% CI, 31%-58%); those with KRAS wild-type disease (n = 52) had a confirmed ORR of 17% (95% CI, 8%-30%).

Additional data from the subgroup of patients with KRAS-mutated disease demonstrated that the median duration of response was 31.1 months (95% CI, 14.8-31.1), the 6-month disease control rate was 70%, and the median PFS was 22 months (95% CI, 11.1-36.6).

Lurbinectedin/Atezolizumab Combination Improves Survival in ES-SCLC

Frontline maintenance with the combination of lurbinectedin (Zepzelca) and atezolizumab (Tecentriq) led to statistically significant improvement in OS and PFS vs atezolizumab monotherapy in adult patients with extensive-stage small cell lung cancer who had received induction therapy with carboplatin, etoposide, and atezolizumab, according to findings from the ongoing phase 3 IMforte trial (NCT05091567).

Detailed topline data from IMforte will be submitted for presentation at an upcoming medical meeting.