Lilly brings second oral SERD to market for breast cancer
The FDA has approved Eli Lilly's oral selective oestrogen receptor degrader (SERD) imlunestrant as a treatment for relapsed or refractory advanced breast cancer with a specific mutation in the oestrogen receptor.
The drug – which will be sold in the US under the Inluriyo trade name – is only the second drug in the oral SERD category to come to market after Menarini/Stemline's Orserdu (elacestrant), which was given the green light in 2023.
Like Orserdu, Inluriyo has been approved by the US regulator with a similar second-line indication for HR-positive, HER2-negative breast cancer patients with ESR1 mutations whose disease progressed after at least one line of endocrine therapy.
According to Lilly, around half of all patients with HR+/HER2- advanced breast cancer will develop an ESR1 mutation after first-line treatment with aromatase inhibitor-based endocrine therapy, and the alteration can contribute to treatment resistance.
Inluriyo's approval stems from the phase 3 EMBER-3 trial, which found that the drug reduced the risk of disease progression or death by 38% compared to endocrine therapy with aromatase inhibitor exemestane or injectable SERD fulvestrant.
The benefit of the drug was confined to the ESR1-mutated population, with a non-significant, 13% reduction in progression-free survival (PFS) in the all-comer setting that included patients without ESR1 mutations.
Orserdu did manage a statistically significant improvement on that measure for the overall patient group in the EMERALD trial, although the data was not deemed strong enough by the FDA to allow its use in ESR1 wild-type patients.
Earlier this week, Roche reported a similar all-comer result in its second-line trial of giredestrant – called evERA – but, as the study was enriched for ESR1 patients, it remains to be seen if that will be considered strong enough for a broader, all-comer label.
Inluriyo's approval was welcomed by the Living Beyond Breast Cancer organisation for offering patients "an additional treatment option, offering them the potential for flexibility in their daily lives and disease management, and - above all - renewed hope for the future."
The next stage for the oral SERD category will be to try to move the drugs into earlier-line settings. To that end, Lilly is running the EMBER-4 trial of Inluriyo as an adjuvant (post-surgery) therapy for people with earlier-stage HR+/HER2- breast cancer.
Menarini is also looking at an adjuvant indication for Orserdu with the ELEGANT trial, and AstraZeneca recently reported encouraging first-line data with its oral SERD camizestrant in the SERENA-6 trial, and has two adjuvant trials on the go (CAMBRIA-1 and CAMBRIA-2).
Roche, meanwhile, is going after both adjuvant and first-line use of giredestrant, respectively, in the lidERA and persevERA studies.
Lilly said it will launch Inluriyo in the next few weeks with a list price of $22,500 for a four-week supply, which seems to be a little below the $24,000 price tag reported for Orserdu at launch.
EU okay for Alzheimer's drug
Also this week, Lilly claimed EU approval for its Alzheimer's disease therapy Kisunla (donanemab) by the European Commission as a treatment for patients in the early stages of the disease, with confirmed amyloid pathology, who have one or zero copies of the ApoE4 gene.
Kisunla was recommended for approval by the EMA's human medicines committee in July, becoming the second amyloid-targeting drug for Alzheimer's in the EU after Eisai/Biogen's Leqembi (lecanemab), which got the go-ahead in April and launched in its first markets last month.
