Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Stratifieringsfaktorer i RELAY

I RELAY stratifierades patienterna efter kön, geografisk region, EGFR-mutationstyp och EGFR-testmetod.

Study design

The RELAY trial was a phase 3, global, multicenter, randomized, double-blind, placebo-controlled trial in patients (N=449) with previously untreated EGFR mutation-positive, metastatic NSCLC. All patients had an EGFR mutation of exon 19 deletion or exon 21 L858R and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, EGFR status, and EGFR testing method) to receive treatment with erlotinib (150 mg/day) plus ramucirumab (10 mg/kg every 2 weeks; n=224) or placebo (10 mg/kg every 2 weeks; n=225) until disease progression or unacceptable toxicity.1

Stratification

Stratification Factors

Patients were stratified by

  • sex (male vs female)

  • geographic region (East Asia vs other)

  • EGFR status (exon 19 deletion vs exon 21 L858R substitution mutation), and

  • EGFR testing method (Therascreen® [Qiagen] or Cobas® [Roche] vs other PCR and sequencing-based methods).1

The randomization strata (gender, geographic region, EGFR mutation type, and EGFR testing method) per IWRS for the ITT population are summarized in Table 1

Table 1. Stratification Factors at Randomization per IWRS ITT Population2

Factor, n (%)

Ramucirumab + Erlotinib
(n=224)

Erlotinib + Placebo
(n=225)

Sex

Male

83 (37.1)

83 (36.9)

Female

141 (62.9)

142 (63.1)

Geographic Regiona

East Asia

166 (74.1)

170 (75.6)

Other

58 (25.9)

55 (24.4)

EGFR Mutation Type

Exon 19 deletion

123 (54.9)

121 (53.8)

Exon 21 L858R substitution mutation

101 (45.1)

104 (46.2)

EGFR Testing Method

Therascreen® (Qiagen) and Cobas® (Roche)

93 (41.5)

96 (42.7)

Other PCR and sequencing-based methods

131 (58.5)

129 (57.3)

Abbreviations: EGFR = epidermal growth factor receptor; ITT = intent-to-treat; IWRS = interactive voice/web response system; PCR = polymerase chain reaction. 

a East Asia includes South Korea, Hong Kong, Japan, and Taiwan, and Other includes Canada, France, Germany, Italy, Romania, Spain, Turkey, United States, and United Kingdom.

Stratification Rationale

The stratification factors for the RELAY study were identified as variables with the potential to influence the primary objective of PFS. The rationale for each of the selected stratification factors is provided in Table 2.

Table 2. Rationale for RELAY Stratification2

Stratification Factor

Stratification Categories

Rationale

Sex

Male vs female

Gender is linked with prognosis.

Region

East Asia vs other

Potential regional heterogeneity of standards of care. 

EGFR mutation type

Exon 19 deletion vs exon 21 L858R substitution mutation

Patients with EGFR mutations benefit from targeted therapy whether it is exon 19 deletion or exon 21 substitution mutation; however, the degree of benefit may differ based on the type of mutation.

EGFR testing method

Therascreen® (Qiagen) and Cobas® (Roche) vs other PCR and sequencing-based methods

Based on regulatory input and due to concerns that the heterogeneity in testing methods may increase the enrollment of patients with false positive EGFR mutations.

Abbreviations: EGFR = epidermal growth factor receptor; PCR = polymerase chain reaction. 

References

1. Nakagawa K, Garon EB, Seto T, et al. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(12):1655-1669. https://doi.org/10.1016/S1470-2045(19)30634-5

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

ITT = intent-to-treat

IWRS = interactive voice/web response system

NSCLC = non-small cell lung cancer

PCR = polymerase chain reaction

PFS = progression-free survival

PS = performance status

Datum fӧr senaste ӧversyn 2019 M07 26


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