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Before this trial there was nothing to offer someone whose basal cell carcinoma had outgrown or outlasted the hedgehog pill. Immunotherapy shrank the tumour in about a third of them, and it is now the standard second treatment.
Until February 2021 there was no standard treatment for locally advanced basal cell carcinoma after a hedgehog inhibitor, and since most people either progress or stop the pill because of its side effects, that gap covered the majority of patients who ever start one. This open-label single-arm trial at 38 centres in Canada, Europe and the United States enrolled patients who had progressed on, could not tolerate, or had no better than stable disease after nine months of hedgehog inhibitor therapy, and gave cemiplimab 350 mg every three weeks for up to 93 weeks.
Eighty-four patients were treated between November 2017 and January 2019. At a median follow-up of 15 months, objective response by independent central review was seen in 26 of 84 (31 per cent, 95 per cent confidence interval 21 to 42), with five complete responses (6 per cent) and 21 partial responses (25 per cent).
Toxicity was that of PD-1 blockade and it was not trivial in this elderly population: grade 3 or 4 treatment-emergent adverse events in 40 of 84 (48 per cent), most commonly hypertension and colitis at 5 per cent each, and serious treatment-emergent events in 29 (35 per cent). There were no treatment-related deaths.
A response rate of 31 per cent is lower than the 43 to 68 per cent reported for first-line hedgehog inhibitors, but the comparison is unfair: this is a population selected for hedgehog failure. What the trial establishes is a second line where there was none. Basal cell carcinoma, long thought a cold tumour because it rarely spreads, turns out to respond to checkpoint blockade, which fits its very high ultraviolet mutational burden.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
84 treated.
26 of 84 patients; 95 per cent confidence interval 21 to 42; 5 complete and 21 partial responses
Source40 of 84 patients; serious treatment-emergent events in 35 per cent
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response by independent central reviewprimary | Cemiplimab 350 mg every 3 weeks | 84 | 31% | - | - | link |
| Grade 3 or 4 treatment-emergent adverse events | Cemiplimab 350 mg every 3 weeks | 84 | 48% | - | - | link |
Shares VISMONEO (vismodegib before surgery for locally advanced basal cell carcinoma), STEVIE (vismodegib in ordinary practice), BOLT, ERIVANCE BCC.
Shares VISMONEO (vismodegib before surgery for locally advanced basal cell carcinoma), STEVIE (vismodegib in ordinary practice), BOLT, ERIVANCE BCC.
Shares STEVIE (vismodegib in ordinary practice), ERIVANCE BCC, Why people stop taking hedgehog inhibitors, Basal cell carcinoma.
Shares STEVIE (vismodegib in ordinary practice), Why people stop taking hedgehog inhibitors, Locally advanced and metastatic basal cell carcinoma, Basal cell carcinoma.
Shares Sanofi, Regeneron, Immune-related adverse events (irAEs), Cemiplimab.
Shares Sanofi, Regeneron, Immune-related adverse events (irAEs), Cemiplimab.
Shares Sanofi, Regeneron, Cemiplimab, PD-1.
Shares Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy, Locally advanced and metastatic basal cell carcinoma, Skin cancer (all types).