Erika Hamilton, Chair, Executive Committee Breast and Breast Program Lead at Sarah Cannon Research Institute, shared a post on LinkedIn:
“Big news is Breast Cancer, Roche reports positive data in the adjuvant setting for their oral SERD giredestrant.
If approved, this would be the first novel endocrine backbone in the breast cancer curative setting in decades.
Multiple oral SERDs with positive data in the metastatic seating, multiple at FDA for consideration currently, one already approved (elacestrant). Why is this different?
- Benefit in the metastatic endocrine pre-treated setting has been restricted to those patients with ESR1m. In the curative setting ESR1 mutations are extremely rare. This would be an all comer benefit not linked to a genomic alteration.
- Why would we anticipate seeing benefit in all comers if we didn’t in the metastatic setting?
Remember oral SERDs haven’t been inferior in anyone, they just weren’t statistically “better” in the wile types.
The main problem in the metastatic setting is endocrine resistance. ESR1m is a resistance mechanism that emerges due to high estrogen dependence and is likely a surrogate marker for higher likelihood of endocrine sensitivity. In the adjuvant setting, we shouldn’t have endocrine resistance and therefore probably don’t need an enrichment factor like ESR1 to get more patients whose tumors are endocrine sensitive.
- Different side effect profile – Will be very interring to see at presentation. Oral SERDs have been well tolerated in the metastatic setting but we know the ‘tolerability threshold’ is different in the curative setting. We have seen less arthralgias, less sexual side effects. Will be intesting to see the data in adjuvant.”
You can read the full article here.
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