Expanding Patient Response to Immunotherapies

Checkmate Pharmaceuticals is investigating CMP-001 across multiple tumor types in combination with several checkpoint inhibitor immunotherapies in melanoma and head and neck cancer. CMP-001 is a potent and highly selective advanced biological construct designed to enter cells associated with solid tumors and activate TLR9 in patients with various types of cancers. We believe that CMP-001 has the potential to provide synergistic clinical benefits when delivered with checkpoint inhibitor immunotherapy.

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


Melanoma is a serious form of skin cancer that arises from a particular skin cell type called a melanocyte. Melanoma is a particularly dangerous form of cancer because of its ability to spread to other organs rapidly if not surgically removed at an early stage, as well as low response rates and limited durability of response when treated with commonly used chemotherapeutics. In 2020, melanoma of the skin is estimated to be the fifth most diagnosed cancer, and accounts for approximately 1% of all skin cancers in the U.S. According to the American Cancer Society, there will be an estimated 100,350 new diagnoses and approximately 6,850 patients will die as a result of melanoma in the United States in 2020.

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)

Lung cancer is the second most commonly diagnosed cancer. Approximately 80-85% of lung cancers are non-small cell lung cancer (NSCLC). Because early stage lung cancer is often asymptomatic, approximately 80% of people with NSCLC are diagnosed with late stage disease. Checkpoint inhibitors, a type of immunotherapy that releases the brakes on the immune system, are used frequently as a therapeutic option for people with certain types of advanced NSCLC—both at initial diagnosis and for cancer that returns after treatment.

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)

Head and Neck Squamous Cell Carcinoma (HNSCC) represents a number of different malignant tumors that develop in or around the throat, larynx, nose, sinuses and mouth, and accounts for approximately 3.6% of all cancers in the United States. HNSCC is more than twice as prevalent among men. Treatments for HNSCC can include surgery, radiation therapy, chemotherapy, targeted therapy, or a combination of treatments including immunotherapy.

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.

Investigator-sponsored exploratory studies of CMP-001 early in a patient’s treatment journey:
  • CMP-001+ nivolumab/ipilimumab: colorectal cancer (Sheba Medical Center, Tel Aviv)
  • CMP-001: Neoadjuvant triple negative breast cancer (TNBC) (University of Lausanne, Switzerland)
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