CRC
Keytruda in monotherapy for MSI-h/dMMR mCRC
KEYTRUDA® is indicated for the first-line treatment of metastatic microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults1.
Atypical responses (ie, an initial transient increase in tumor size or small new lesions within the first few months, followed by tumor shrinkage) have been observed. Clinically stable patients with initial evidence of disease progression should remain on treatment until disease progression is confirmed.
dMMR: mismatch repair deficient; MSI-H: microsatellite instability-high.
A multicenter, randomized, open-label, active-controlled trial
bPatients randomized to chemotherapy were offered KEYTRUDA® at time of disease progression.
BICR: blinded independent central review; CRC: colorectal cancer; dMMR: mismatch repair deficient; DOR: duration of response; FOLFIRI: leucovorin, fluorouracil, and irinotecan; FU: fluorouracil;
IHC: immunohistochemistry; IV: intravenous; mFOLFOX6: modified leucovorin, fluorouracil, and oxaliplatin;
MMR: mismatch repair; MSI: microsatellite instability; MSI-H: microsatellite instability-high; ORR: objective response rate; OS: overall survival; PCR: polymerase chain reaction; PFS: progression-free survival; Q2W: every 2 weeks; Q3W: every 3 weeks; RECIST v1.1: Response Evaluation Criteria In Solid Tumors v1.1.
| Baseline Characteristics | N=307 |
|---|---|
| Median age, years | 63 (range: 24 to 93) |
| Age ≥65 years, % | 47 |
| Male, % | 50 |
| Race/ethnicity, % | |
| White | 75 |
| Asian | 16 |
| ECOG PS, % | |
| 0 | 52 |
| 1 | 48 |
| Mutation Status, % | |
| BRAF V600E | 25 |
| KRAS/NRAS | 24 |
| SoC Chemotherapy Received | n=143 |
|---|---|
| mFOLFOX6 with or without bevacizumab or cetuximab, % | 56 |
| FOLFIRI with or without bevacizumab or cetuximab, % | 44 |
BRAF: v-Raf murine sarcoma viral oncogene homolog B; ECOG PS: Eastern Cooperative Oncology Group performance status; FOLFIRI: leucovorin, fluorouracil, and irinotecan; KRAS: Kirsten rat sarcoma viral oncogene homolog; mFOLFOX6: modified leucovorin, fluorouracil, and oxaliplatin; NRAS: neuroblastoma RAS viral oncogene homolog; SoC: standard of care.
PRIMARY ENDPOINT (ITT population)
Adapted from Andre et al. 2020.2
Higher response rates with KEYTRUDA® vs chemotherapy in KEYNOTE-1771,2
Adapted from Andre et al. 2020.2
aBased on Kaplan-Meier estimation.
CI: confidence interval; CR: complete response; DOR: duration of response; ORR: objective response rate; PR:
partial response; SoC: standard of care.
Chart modified according to Andre T, et al. J Clin Oncol. 2020.2
BRAF: v-Raf murine sarcoma viral oncogene homolog B; CI: confidence interval; ECOG PS: Eastern Cooperative Oncology Group performance status;
HR: hazard ratio; KRAS: Kirsten rat sarcoma viral oncogene homolog; NRAS: neuroblastoma RAS viral oncogene homolog; WT: Wild-Type.
With KEYTRUDA® three times fewer grade ≥ 3 treatment-related adverse events: 22% vs 66%2
Adverse events (AEs) with incidence ≥ 20 %b in any group in all treated patients2
Adapted from Andre et al. 2020.2
aOne grade 5 event of intestinal perforation.
bTreatment-related adverse events. Table modified according to Andre T, et al. J Clin Oncol. 2020.2
Refer to SmPC for complete safety profile.
AEs: adverse events.
- SmPC KEYTRUDA.
- Andre et al. Pembrolizumab versus chemotherapy for microsatellite instability-high/ mismatch repair deficient metastatic colorectal cancer: The phase 3 KEYNOTE-177 Study. Abstract LBA4 presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; 29 – 31 May 2020; Chicago, IL. J Clin Oncol. 2020;28(18 suppl). doi: 10.1200/JCO.2020.38. 18_suppl.LBA4.
Please consult the prescribing information before prescribing.