Expanding Patient Response to Immunotherapies
Differentiated Approach for CMP-001
- Generally manageable adverse events
- Potential for anti-tumor activity in patients whose tumors were previously resistant to PD-1 inhibition, when used in combination with checkpoint inhibitors
- Local and systemic immune responses
- Designed to induce tumor specific T cell response
- Potential for innate immune activation via the TLR9 pathway represents a unique and differentiated mechanism for the treatment of cancer
- Compatible with other treatment modalities
About the study in advanced refractory melanoma
Early clinical studies have shown that CMP-001, in combination with Merck’s Keytruda® (pembrolizumab), can reverse resistance to PD-1 inhibition in people with melanoma. Results from our early clinical studies in advanced melanoma show durable responses with a favorable safety profile.
Preliminary data from this study was reported at SITC in 2019. We intend to conduct a new multicenter Phase 2 study of CMP-001 in combination with intravenous anti PD-1 antibody in patients with anti-PD-1 refractory melanoma.
About the study in neoadjuvant melanoma
Along with our collaborators at the University of Pittsburgh, we are exploring the combination of CMP-001 + Opdivo® (nivolumab), an FDA approved checkpoint inhibitor immunotherapy, for the treatment of melanoma that has spread into lymph nodes in people who are candidates for surgery (neoadjuvant).
Preliminary data from this study was reported at SITC in 2019.
About front-line (PD-1-naïve) melanoma
We intend to conduct a multicenter, Phase 2 randomized, active-controlled, open-label study of CMP-001 in combination with anti-PD-1 antibody versus anti-PD-1 antibody alone in subjects with front-line melanoma.
More information about our studies investigating CMP-001 in melanoma can be found at clinicaltrials.gov.
Non-small Cell Lung Cancer (NSCLC)
We are evaluating CMP-001 in combination with Tecentriq® (atezolizumab), Roche Genentech’s anti-PD-L1 immunotherapy, in individuals with advanced NSCLC whose disease has progressed after treatment with a checkpoint inhibitor. Patient enrollment in this study is ongoing.
Head and Neck Squamous Cell Carcinoma (HNSCC)
Pfizer is investigating the use of CMP-001 in combination with Bavencio ® (avelumab), an FDA approved PD-L1 immunotherapy, and other immune modulators for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the head and neck (SCCHN). Study combinations include:
- CMP-001 + avelumab
- CMP-001 + avelumab + utomilumab (4-1BB agonist mAb)
- CMP-001 + avelumab + PF-04518600 (OX40 agonist mAb)
This study is currently enrolling patients.
We also intend to initiate a Phase 2 study of CMP-001 and pembrolizumab in patients with SCCHN that have not been previously treated with PD-1 blockade.
More information about our studies investigating CMP-001 in SCCHN can be found at clinicaltrials.gov
Our clinical approach to enhancing patient response to therapy: earlier treatments, expanding indications
Based on the clinical data we have generated to date, including the generally manageable adverse events we have observed, we believe there is an opportunity for CMP-001 to be developed as a differentiated immuno-oncology therapy. On the strength of the clinical results observed in multiple settings of melanoma, we intend to initiate additional trials with CMP-001 in combination with anti-PD-1 antibodies. We are expanding our programs with CMP-001 to other tumor types and earlier in a patient’s treatment journey including triple negative breast cancer and colorectal cancer.
- CMP-001+ nivolumab/ipilimumab: colorectal cancer (Sheba Medical Center, Tel Aviv)
- CMP-001: Neoadjuvant triple negative breast cancer (TNBC) (University of Lausanne, Switzerland)