Eli Lilly: FDA approves Inluriyo (imlunestrant) plus Verzenio for ER+, HER2–, ESR1‑mutated advanced/metastatic breast cancer
- FDA granted full approval to Inluriyo (imlunestrant) plus Verzenio (abemaciclib) for adults with ER+, HER2–, ESR1‑mutated locally advanced or metastatic breast cancer after progression on ≥1 endocrine therapy.
- Phase 3 EMBER‑3 (n=159) showed median PFS 11.1 months with the combination versus 5.5 months with Inluriyo alone (HR=0.53; 95% CI 0.35–0.80).
- Common adverse events in the combination arm included decreased neutrophils (86%; Grade 3–4 21%) and diarrhea (86%; Grade 3–4 9%); serious adverse reactions occurred in 21% and fatal reactions in 3.8%.
- EMBER‑4 adjuvant trial is enrolling >8,000 patients across 650+ sites in 30+ countries, with initial results anticipated in 2027; the combination is now available in the US.
Approval and indication
The FDA granted full approval for Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) to treat adults with estrogen receptor–positive (ER+), HER2–, ESR1‑mutated locally advanced or metastatic breast cancer, as detected by an FDA‑authorized test, after disease progression following at least one line of endocrine therapy.
Key EMBER‑3 results
The approval is supported by Phase 3 EMBER‑3 (n=159). Patients who switched to imlunestrant plus abemaciclib after prior aromatase inhibitor (± prior CDK4/6 inhibitor) had median progression‑free survival of 11.1 months versus 5.5 months with imlunestrant alone (HR=0.53; 95% CI, 0.35–0.80).
Safety and monitoring
Most adverse events were Grade 1–2, but notable laboratory and clinical toxicities occurred: decreased neutrophils (86%; Grade 3–4 21%), diarrhea (86%; Grade 3–4 9%), ALT/AST increases (ALT any grade 33%, AST any grade 36%), venous thromboembolism (4.8%) and ILD/pneumonitis (2.9%). Serious adverse reactions occurred in 21% of combination patients; fatal reactions in 3.8%. Verzenio monitoring recommendations include baseline CBC and LFTs, every 2 weeks for 2 months, then monthly for 2 months; follow full prescribing information for dose modifications. Both agents carry embryo‑fetal toxicity warnings and contraception guidance.
Ongoing studies and availability
Inluriyo is being evaluated in the Phase 3 EMBER‑4 adjuvant trial (>8,000 patients); initial results are expected in 2027. The imlunestrant (200 mg tablets; 400 mg once daily on an empty stomach) plus abemaciclib combination is available in the United States.
Source: Lilly