Study Results
Explore results from the CHRYSALIS trial.
Treatment with RYBREVANT® was evaluated in the CHRYSALIS trial
CHRYSALIS is a multicenter, open-label, multicohort study that included 129 adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease progressed on or after platinum-based chemotherapy.1
Efficacy was evaluated in 81 patients with locally advanced or metastatic NSCLC who had EGFR exon 20 insertion mutations as determined by prospective local testing using tissue (94%) and/or plasma (6%) samples, whose disease had progressed on or after platinum-based chemotherapy.1
Efficacy was evaluated by ORR according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as evaluated by Blinded Independent Central Review (BICR). An additional efficacy outcome measure was duration of response (DOR) by BICR.1
| Baseline Characteristics for the Efficacy Population (n=81)1 | |
|---|---|
| Median age | 62 years (range: 42-84 years) |
| Female / Male | 59% / 41% |
| Asian | 49% |
| White | 37% |
| Black | 2.5% |
| Baseline body weight <80kg | 74% |
| Adenocarcinoma | 95% |
| Prior Immunotherapy | 46% |
| ECOG performance status 1 | 67% |
| Median number of prior therapies | 2 (range: 1-7 therapies) |
| Never smoked | 53% |
| Metastatic disease | 100% |
| Previous treatment for brain metastases | 22% |
ECOG, Eastern Cooperative Oncology Group.
RYBREVANT® demonstrated durable responses in the CHRYSALIS trial
ORR in patients with EGFR exon 20 insertion mutations (n=81)1
*According to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as evaluated by Blinded Independent Central Review (BICR).
The median DOR was 11.1 months (95% CI: 6.9, NE)1†
- 63% of patients who responded had a DOR of ≥6 months
†Based on Kaplan-Meier estimates.
Amivantamab-vmjw (RYBREVANT®) is recommended in the NCCN Guidelines
The NCCN Guidelines recommend amivantamab-vmjw (RYBREVANT®) as a subsequent therapy option for patients with EGFR+ mNSCLC with exon 20 insertion mutations who have progressed on initial systemic therapy2‡
‡See the NCCN Guidelines for detailed recommendations, including other treatment options.2
BICR, Blinded Independent Central Review; CI, confidence interval; CR, complete response; DOR, duration of response; EGFR, epidermal growth factor receptor; ILD, Interstitial Lung Disease; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network® (NCCN®); NE, not estimable; ORR, overall response rate; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.
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References
1. RYBREVANT® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed September 26, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.