Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer
Eli Lilly's oral selective oestrogen receptor degrader (SERD) imlunestrant (Inluriyo), has received a second FDA approval, this time in combination with CDK4/6 inhibitor abemaciclib (Verzenio), another Lilly drug.
The combination is approved or the same cohort as the monotherapy: ER-positive, HER2-negative breast cancer patients with ESR1 mutations whose disease progressed after at least one line of endocrine therapy. However, in the phase 3 EMBER-3 trial, the combination was found to double median progression-free survival compared to Inluriyo alone, with a PFS of 11 months vs five and half.
“Today’s full approval extends what Inluriyo in combination with Verzenio can do for patients, with a regimen that has confirmed benefit, is aligned to the clinically proven treatment paradigm of changing therapy at clinical progression, and doesn’t introduce burdensome monitoring requirements for patients or physicians," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "In fact, all available evidence suggests that switching endocrine therapy and CDK4/6 inhibitor at clinical progression improves patient outcomes more than switching therapy earlier. Utilising this evidence-based practice spares early exposure to 2 additional side effects, reduces patient anxiety from unnecessary testing, and mitigates avoidable costs to the healthcare system."
The all-oral combination of an SERD and a CDK4/6 inhibitor allows the drugs to target two different drivers of tumour growth -- one degrades mutated oestrogen receptors while the other targets the CDK4/6 proteins that control cancer cells' rates of division.
The combination did cause more discontinuations due to adverse affects than the monotherapy, as might be expected, but a small number in both cases: 3.4% of patients taking the combination vs 1% on Inluriyo alone.
"We have an urgent need for effective and safe treatment options for patients with disease progression on adjuvant or first-line therapy. Combining therapies that work on two distinct drivers of tumour growth—the estrogen receptor and CDK4/6—is an important strategy to help address treatment resistance,” Dr Komal Jhaveri of Memorial Sloan Kettering Cancer Center, principal investigator for the EMBER-3 and EMBER-4 trials, said in a statement.
EMBER-4, an additional 8,000-patient study of Inluriyo, is assessing the drug's potential in reducing recurrence in early-stage breast cancer after standard of care endocrine therapy. Those results are expected some time next year.
