A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)

A phase 3 trial of Rovalpituzumab tesirine and Dexamethasone in Small-cell lung cancer, run by AbbVie, recorded as terminated on the registry.

Also called: MERU

A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU) is a phase 3 interventional study registered as NCT03033511 by AbbVie, with 748 participants recorded, started 2017-02-07 and due to reach its primary completion in 2019-11-20. Interventions recorded: Placebo for dexamethasone, Placebo for rovalpituzumab tesirine, Rovalpituzumab tesirine, Dexamethasone. Conditions recorded: Small Cell Lung Cancer.

Linked to the drug Rovalpituzumab tesirine because the registry names it among its interventions and Small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.

Setting

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)

Phase

Phase 3

Sponsor

AbbVie

Registry

Started

2017-02-07

Reported

2020

Enrolled

748 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

748 enrolled

Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)primarysurvival endpoint

Median 9.8 vs 8.5 months with Placebo compared with Rovalpituzumab Tesirine/Dexamethasone; about 1.3 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 7 percent higher chance of the event at any given time (hazard ratio 1.07, likely range 0.84 to 1.36).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
These results apply to the people the trial enrolled: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU). People in a different situation may not see the same effect.

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.

748 enrolled.

Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)primary

HR 1.07 (0.84 to 1.36) · p = 0.537

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95% CI 8.38 to 10.87; Figures from the ClinicalTrials.gov results section (first posted 2020-12-21), not from a publication · 95% CI 7.26 to 10.18

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)primary	Placebo	240	9.79 months	1.07 (0.84 to 1.36)	0.537	link
	Rovalpituzumab Tesirine/Dexamethasone	217	8.48 months	1.07 (0.84 to 1.36)	0.537	link

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cancers

Extensive-stage small-cell lung cancer Small-cell lung cancer

drugs

ApprovedGlucocorticoid

Dexamethasone · Decadron (historic) / Hemady / Neofordex

WithdrawnADC

Rovalpituzumab tesirine

companies

AbbVie (incl. ImmunoGen, Capstan)