Recent Advances in Oncology: FDA Approvals, Promising Therapies, and Evolving Treatment Strategies
核心洞察
The FDA approved inavolisib plus palbociclib/fulvestrant for endocrine-resistant, PIK3CA-mutated, HR+/HER2- advanced breast cancer (搜索), significantly improving progression-free survival.
Zolbetuximab combined with chemotherapy received FDA approval for first-line treatment of CLDN18.2+ gastric or GEJ adenocarcinoma (搜索), based on positive results from SPOTLIGHT and GLOW trials.
Neoadjuvant pembrolizumab followed by adjuvant pembrolizumab demonstrated a significant improvement in event-free survival in resected stage III/IVA head and neck squamous cell carcinoma (搜索).
Recent weeks have seen significant developments in oncology, marked by new FDA approvals, promising therapeutic strategies, and evolving approaches to cancer treatment. These advancements offer new hope for patients across various cancer types.
FDA Approves Inavolisib for Advanced Breast Cancer
The FDA approved inavolisib (Itovebi) in combination with palbociclib (Ibrance) and fulvestrant (Faslodex) for adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer (搜索). This approval, announced on October 10, 2024, is based on the phase 3 INAVO120 study (NCT04191499), which demonstrated a significant improvement in progression-free survival (PFS) with the inavolisib triplet compared to palbociclib/fulvestrant alone. The median PFS was 15.0 months (95% CI, 11.3-20.5) in the inavolisib arm versus 7.3 months (95% CI, 5.6-9.3) in the control arm (HR, 0.43; 95% CI, 0.32-0.59; P < .0001).
Zolbetuximab Approved for Gastric and 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. The approval was supported by data from the phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials. In SPOTLIGHT, the addition of zolbetuximab to mFOLFOX6 improved progression-free survival (PFS) vs placebo plus mFOLFOX6 (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).
Pembrolizumab Shows Promise in Head and Neck Cancer
Data from the phase 3 KEYNOTE-689 trial (NCT03765918) demonstrated that neoadjuvant pembrolizumab (Keytruda), followed by pembrolizumab plus radiotherapy with or without cisplatin, and maintenance pembrolizumab, resulted in a significant improvement in event-free survival over adjuvant radiotherapy with or without cisplatin in patients with newly diagnosed, resected stage III or IVA, locally advanced head and neck squamous cell carcinoma (搜索). A significant improvement in major pathological response was also observed in the pembrolizumab arm, as well as a trend toward improvement in overall survival (OS).
Other Key Developments
- Osimertinib Approved for EGFR+ NSCLC: Osimertinib (Tagrisso) received FDA approval for locally advanced, unresectable, stage III non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutations after chemoradiation, based on the phase 3 LAURA study (NCT03521154).
- Selpercatinib Approved for RET Fusion+ Medullary Thyroid Cancer: Selpercatinib (Retevmo) was granted traditional approval for RET fusion-positive, advanced or metastatic medullary thyroid cancer, supported by the phase 3 LIBRETTO-531 study (NCT04211337).
- Talazoparib Plus Enzalutamide Improves OS in mCRPC: Updated data from the phase 3 TALAPRO-2 study (NCT03395197) showed that talazoparib (Talzenna) paired with enzalutamide (Xtandi) improved OS vs single-agent enzalutamide in patients with metastatic castration-resistant prostate cancer.
- Optune Lua Approved for Metastatic NSCLC: The FDA approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for metastatic non–small cell lung cancer after platinum-based chemotherapy, based on the phase 3 LUNAR trial (NCT02973789).
These recent developments highlight the ongoing progress in oncology research and the continuous effort to improve treatment options and outcomes for cancer patients.