~2X mPFS: 11.4 months (95% CI: 9.8, 13.7) with RYBREVANT® + chemotherapy vs 6.7 months (95% CI: 5.6, 7.3) with chemotherapy alone1
HR, hazard ratio.
Efficacy
A first-in-class, Phase 3 study evaluating RYBREVANT® + chemotherapy for first-line EGFR exon 20 insertion mutations1
Treatment with RYBREVANT® + chemotherapy was evaluated in the PAPILLON Phase 3 study
PAPILLON was a randomized, open-label, multicenter, Phase 3 study in 308 patients, comparing treatment with RYBREVANT® in combination with chemotherapy (carboplatin and pemetrexed) vs chemotherapy alone in patients with previously untreated, locally advanced or metastatic NSCLC with documented EGFR exon 20 insertion mutations, an ECOG PS of 0 or 1, and adequate organ and bone marrow function.1,2*
Primary Endpoint:
The primary efficacy endpoint was evaluated by PFS according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as evaluated by BICR.1
*Patients with definitively treated, clinically stable, asymptomatic brain metastases and off corticosteroids for at least 2 weeks were eligible. Patients with a medical history of ILD or active ILD were excluded.1
Treatment with RYBREVANT® + chemotherapy was evaluated in the PAPILLON Phase 3 study1
- Removed as stratification factor since only 4 patients had prior EGFR TKI use (brief monotherapy with common EGFR TKIs was allowed if lack of response was documented)
- Patients with brain metastases were eligible if they received definitive treatment and were asymptomatic, clinically stable, and off corticosteroid treatment for ≥2 weeks prior to randomization
- Key statistical assumption: 300 patients with 200 events needed for 90% power to detect an HR of 0.625 (estimated PFS of 8 vs 5 months). PFS, ORR, and then OS were included in hierarchical testing
- These secondary endpoints (time to subsequent therapy and symptomatic progression-free survival) will be presented at a future congress
- Crossover was only allowed after BICR confirmation of disease progression; RYBREVANT monotherapy on Q3W dosing per main study
BICR, blinded independent central review; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; ILD, interstitial lung disease; NSCLC, non-small cell lung cancer; ORR, overall response rate; PFS, progression-free survival.
Baseline characteristics in PAPILLON were well-balanced across treatment types2
*Race or ethnic group was reported by the patients. In some regions, reporting of race was not required. One patient reported being of multiple races.
†Other is a grouped term including Black, American Indian or Alaska Native, multiple, and unknown.
‡Other histologic types included bronchoalveolar carcinoma, non–squamous-cell non–small-cell lung cancer, and non–small-cell carcinoma.
For first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 mutations
The first and only targeted therapy to show statistically significant PFS improvement1,3
RYBREVANT® + chemotherapy demonstrated a statistically significant reduction in the risk of progression or death by 60% vs chemotherapy alone, as assessed by a BICR1,2
POWERFUL & TARGETED
Statistically significant PFS results in first-line therapy with RYBREVANT® + chemotherapy1
CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; mPFS, median progression-free survival; NSCLC, non-small cell lung cancer; PFS, progression-free survival.
RYBREVANT® + chemotherapy demonstrated a consistent PFS benefit across patient subgroups2
For first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 mutations
Unprecedented responses from a novel first-line regimen
RYBREVANT® + chemotherapy demonstrated higher responses as assessed by BICR. Deep and fast responses were also observed.1,4
Depth1
- CR was 4% with RYBREVANT® + chemotherapy and 1% with chemotherapy alone
Speed of Response2
- Median TTR was 6.7 weeks (range, 5.1 to 72.5) with RYBREVANT® + chemotherapy and 11.4 weeks (range, 5.1 to 60.2) with chemotherapy alone. TTR was not prespecified
This presentation is for descriptive purposes only. No comparisons should be drawn.
RYBREVANT in combination with carboplatin and pemetrexed demonstrated durable responses as assessed by BICR5
~2X median DOR
Median DOR is 10.1 months (95% CI: 8.5, 13.9) for RYBREVANT® + chemotherapy and 5.6 months (95% CI: 4.4, 6.9) for chemotherapy alone1
While DOR was prespecified, it is based on descriptive statistics and no comparisons should be drawn.
DOR, duration of response.
Interim OS data
While OS results were immature at the current analysis, with 44% of prespecified deaths for the final analysis reported, no trend towards a detriment was observed.1,2
- 48% of the treated patients crossed over from the carboplatin and pemetrexed arm after confirmation of disease progression to receive RYBREVANT® as a single agent1
BICR, blinded independent central review; CI, confidence interval; CR, complete response; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression-free survival; TTR, time to response.
Explore
A targeted first-line treatment with a manageable safety profile.
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References
1. RYBREVANT® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
2. Zhou C, Tang K-J, Cho BC, et al; PAPILLON Investigators. Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions. N Engl J Med. 2023;389(22):2039-2051.
3. The Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen submits supplemental biologics license application to the U.S. Food and Drug Administration seeking approval of RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic EGFR exon 20 insertion mutation-positive non-small cell lung cancer. Accessed February 15, 2023. https://www.prnewswire.com/news-releases/janssen-submits-supplemental-biologics-license-application-to-the-us-food-and-drug-administration-seeking-approval-of-rybrevant-amivantamab-vmjw-in-combination-with-chemotherapy-for-the-first-line-treatment-of-patients-with-l-301910074.html
4. Data on file. Janssen Biotech, Inc.
5. Zhou C, Tang K-J, Cho BC, et al; PAPILLON Investigators. Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions. Supplementary appendix. N Engl J Med. 2023;389(22):2039-2051.
