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MIRASOL / GOG-3045

The first ADC to extend life in ovarian cancer, for the roughly one-third of tumours with high folate receptor alpha.

PFS 5.62 vs 3.98 months (HR 0.65) and OS 16.46 vs 12.75 months (HR 0.67; NEJM 2023). Ocular toxicity (blurred vision, keratopathy) is frequent but reversible with eye-drop prophylaxis. Full approval March 2024.

Setting
Platinum-resistant ovarian cancer with high folate receptor alpha expression, 1-3 prior lines: mirvetuximab soravtansine vs chemotherapy
Phase
Phase 3
Sponsor
ImmunoGen (AbbVie)
Registry
Headline result
OS 16.46 vs 12.75 months (HR 0.67).
Reported
2023
Enrolled
453

Outcomes

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In plain words
What these results mean for people, not percentages
453 people took part
Progression-free survivalprimarysurrogate endpoint
  • Median 5.6 vs 4 months with Mirvetuximab compared with Chemotherapy; about 1.6 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 35 percent lower chance of the event at any given time (hazard ratio 0.65, likely range 0.52 to 0.81).
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survivalsurvival endpoint
  • Median 16.5 vs 12.8 months with Mirvetuximab compared with Chemotherapy; about 3.7 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 33 percent lower chance of the event at any given time (hazard ratio 0.67, likely range 0.5 to 0.89).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
  • These results apply to the people the trial enrolled: Platinum-resistant ovarian cancer with high folate receptor alpha expression, 1-3 prior lines: mirvetuximab soravtansine vs chemotherapy. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (folate receptor); the result should not be assumed for people whose cancer does not have it.

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.

453 participants enrolled.

Progression-free survivalprimary
HR 0.65 (0.52–0.81)
Mirvetuximab
5.62 mo
Chemotherapy
3.98 mo
Source
Overall survival
HR 0.67 (0.5–0.89)
Mirvetuximab
16.46 mo
Chemotherapy
12.75 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryMirvetuximab2275.62 months0.65 (0.52–0.81)link
Chemotherapy2263.98 months
Overall survivalMirvetuximab16.46 months0.67 (0.5–0.89)link
Chemotherapy12.75 months

Connected

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