The edition · Oncology
An all-oral giredestrant-everolimus regimen lengthened progression-free survival after CDK4/6 inhibitors; tomosynthesis screening missed its interval-cancer endpoint
A phase 3 breast cancer trial leads an oncology edition that also covers a large screening trial with a borderline primary result and a colorectal sequencing trial that closed with 22 patients.
The edition in brief
In evERA, a phase 3 open-label trial of 373 patients with ER-positive, HER2-negative advanced breast cancer progressing after a CDK4/6 inhibitor with endocrine therapy, giredestrant plus everolimus gave median progression-free survival of 8.8 vs 5.5 months overall (HR 0.56, 95% CI 0.44 to 0.71) and 10.0 vs 5.5 months in ESR1-mutated tumours (HR 0.38, 0.27 to 0.54) compared with standard endocrine therapy plus everolimus; adverse event rates were similar. TOSYMA-2 followed screen-negative women in Germany for 24 months: invasive interval cancer rates were 14.2 vs 18.6 per 10,000 with tomosynthesis plus synthesised mammography versus digital mammography (adjusted OR 0.76, 95% CI 0.55 to 1.06; P=0.11), so the primary endpoint was not significant, while the 12-month rate was lower (OR 0.71, 0.52 to 0.97). REVERCE II randomised only 22 patients with refractory RAS wild-type metastatic colorectal cancer before closing, and its overall survival difference (21.9 vs 13.3 months) was not significant. A regulatory entry notes an FDA supplement to tucatinib. A pearl on molecular testing at progression closes the edition.
FDA records a supplement to the tucatinib (Tukysa) application
No prescribing change follows from this FDA record; check the current label if you use tucatinib.
TOSYMA-2: tomosynthesis screening did not significantly cut 24-month interval cancers
Tomosynthesis screening showed a favourable but non-significant trend in interval cancers; the question of mortality benefit remains open.
REVERCE II closed early: sequencing regorafenib and anti-EGFR therapy remains unanswered
No change to sequencing; REVERCE II was too small to answer the question.
At progression on endocrine therapy, ask whether the tumour has been re-profiled
At progression on endocrine therapy, confirm that current tumour genotype, including ESR1, is known before choosing the next line.
evERA: giredestrant plus everolimus nearly doubled progression-free survival in ESR1-mutated breast cancer
Ensure ESR1 status is known at progression; an all-oral giredestrant-everolimus regimen showed longer progression-free survival, but check regulatory status and overall survival data before using it.
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