#Keynote 177 colorectal trial
#Keynote 177 colorectal plus

MSI-H tumors have a lot of neoantigens and a high tumor burden, so there’s a lot of rationale to use immunotherapy in these patients.Ĭould you elaborate on the initial findings that were seen in the phase 2 trials? We also have the results of the phase 2 KEYNOTE-164 trial, which showed good results with pembrolizumab in pretreated patients. This was a very important paper that demonstrated the efficacy of pembrolizumab in this patient population. However, the outcomes with these regimens are not as good in the MSI-H population as they are in the microsatellite stable population.įour years ago, phase 2 data were published in the New England Journal of Medicine regarding the use of pembrolizumab in MSI-H CRC.

#Keynote 177 colorectal plus

OncLive: Could you provide some background on the study?Īndre: The current standard of care is chemotherapy plus or minus cetuximab (Erbitux), panitumumab (Vectibix), or bevacizumab (Avastin).

#Keynote 177 colorectal trial

Antoine Hospital, Assistance Publique Hôpitaux de Paris, discussed the results of the KEYNOTE-177 trial in mCRC. In an interview with OncLive, Andre, professor of medical oncology, University Pierre et Marie Curie (UMPC), and head of the Medical Oncology Department in St. On June 29, 2020, the FDA approved the PD-1 inhibitor for the first-line treatment of patients with unresectable or metastatic MSI-H/dMMR CRC, based on data from the KEYNOTE-177 trial. “ we have an opportunity to cure some patients with immunotherapy,” said Andre. Additionally, the duration of response was not reached in the pembrolizumab arm versus 10.6 months in the chemotherapy arm. The 2-year PFS rates were 48.3% in the pembrolizumab arm versus 18.6% in the chemotherapy arm. “It's very rare to see an improvement in PFS of this magnitude in gastrointestinal oncology,” said Andre, who is lead author of the study The results of the trial, which demonstrated a doubling in progression-free survival (PFS) with pembrolizumab versus standard chemotherapy in patients with newly diagnosed MSI-H mCRC, have also reinforced the importance of conducting biomarker-driven studies, said Andre.Īt a median follow-up of 32.4 months, the median PFS was 16.5 months (95% CI, 5.4-32.4) with pembrolizumab (n = 153) versus 8.2 months (95% CI, 6.1-10.2) with standard chemotherapy with or without bevacizumab (Avastin) or cetuximab (Erbitux n = 154) in patients with MSI-H/dMMR mCRC, translating to a 40% reduction in the risk of disease progression or death (HR, 0.60 95% CI, 0.45-0.80 P =.

Has received prior therapy with an immune checkpoint inhibitor (e.g., anti-programmed cell death -1, anti-PD ligand 1, anti-PD-L2 agent, or anti-cytotoxic T-lymphocyte-associated protein 4 agent, etc.Pembrolizumab (Keytruda) monotherapy has become the new frontline standard of care for patients with microsatellite instability–high (MSI-H)/mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC), according to findings from the phase 3 KEYNOTE-177 trial, said Thierry Andre, MD.

Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization on this study.

Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Radiation therapy within 4 weeks prior to randomization on this study and not recovered to baseline from adverse events due to radiation therapy.

Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization on this study.

Active autoimmune disease that has required systemic treatment in past 2 years.

Currently participating and receiving treatment in another study, or participated in a study of an investigational agent and received treatment, or used an investigational device within 4 weeks of randomization.

May have received prior adjuvant chemotherapy for colorectal cancer as long as it was completed at least 6 months prior to randomization on this study

Has received prior systemic therapy for Stage IV colorectal cancer.