CytomX Therapeutics Announces Initiation of Phase 2 Clinical Trial Evaluating the Anti-PD-L1 Probody CX-072 in Combination with YERVOY® in Patients with Relapsed or Refractory Melanoma
“The initiation of this first Phase 2 study for CX-072 marks the ongoing advancement of our innovative pipeline of Probody therapeutics and reflects our vision for this novel checkpoint inhibitor to become a differentiated centerpiece of combination therapies in multiple cancer types,” said
“Patients whose melanoma has progressed despite prior treatment with checkpoint inhibition remain a significant unmet medical need. This exciting study leverages our unique technology platform to enable a more powerful combination therapy directed against the two best validated pathways in immuno-oncology and could represent a significant advance in outcomes for these patients who have few treatment options,” said
About the PROCLAIM-CX-072-002 Ipilimumab Combination Study
PROCLAIM-CX-072-002 is an open-label, multi-center Phase 2 clinical study (NCT03993379) that allows for the testing of CX-072 in combination with ipilimumab in patients with unresectable or metastatic melanoma whose disease has progressed or relapsed following treatment with a PD-1/PD-L1 immune checkpoint inhibitor. This study will assess the efficacy and tolerability of a fixed dose of 800 mg of CX-072 every three weeks in combination with ipilimumab at the full labelled combination dose and schedule of 3 mg/kg every three weeks for four cycles. CX-072 therapy will be continued once every two weeks after the completion of the combination phase until disease progression. The primary objective is overall response rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with secondary objectives evaluating the safety and tolerability of CX-072. The cohort utilizes a Simon 2 Stage design with approximately 40 patients being enrolled into Stage 1 with additional patients being enrolled into Stage 2, pending the outcome of Stage 1. CytomX anticipates initial data from Stage 1 in 2020.
Additional information on this trial is available at ClinicalTrials.gov using the identifier NCT03993379.
Unmet Need in Relapsed Refractory Melanoma
Melanoma is a life-threatening form of skin cancer. The incidence of melanoma has been increasing over the last 40 years, with about 150K newly diagnosed patients across major markets in 2018. In the unresectable/metastatic setting, approximately 60% of melanoma patients will receive immune checkpoint blockade (~35% of BRAF+ patients and ~75% of BRAF WT) yet ~85% of those patients will progress. For patients with unresectable/metastatic melanoma who progress after PD-1/L1 therapy, there are limited treatment options available.
Updated Top-Line Results from the Phase 1 PROCLAIM-CX-072-001 Ipilimumab Combination Study
This open-label, dose-finding study evaluated CX-072 in combination with ipilimumab in patients with advanced solid tumors. Preliminary data from this trial was first presented at the
The recommended combination dose for further investigation is 3 mg/kg of ipilimumab and 10 mg/kg of CX-072 (dose equivalent of 800 mg). This combination was generally well tolerated with no new safety signals observed. Of the 27 patients treated across all doses, Grade 3/4 treatment related adverse events (TRAE) were reported in 9 (33%) patients and Grade 3/4 immune related adverse events (irAEs) were reported in 6 (22%) patients. Of the 20 patients treated with ipilimumab at 3 mg/kg at varying doses of CX-072, Grade 3/4 TRAEs were reported in 5 (25%) patients and Grade 3/4 irAEs were reported in 3 (15%) patients.
The Company is preparing data from the Phase 1 PROCLAIM-CX-072-001 study for publication.
CytomX Therapeutics Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. In particular, clinical data referenced above for CX-072 including data on efficacy and safety, is based on a limited dataset and a limited number of patients and at specific doses and, in some cases, specific cancer types. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy of CX-072, administered separately or in combination, the potential benefits or applications of CytomX’s Probody platform technology, CytomX’s ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing clinical trials of CX-072 and CX-2009, and the timing of any future clinical trials to be initiated by CytomX or its collaborative partners. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel Probody Platform technology; four of CytomX’s product candidates under its Probody platform are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties; the possibility that the results of early clinical trials may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; CytomX’s dependence on the success of CX-072, CX-2009, CX-2029 and BMS 986249; CytomX’s reliance on third parties for the manufacture of the company’s product candidates; and possible regulatory developments in
PROBODY is a registered trademark of
YERVOY is a registered trademark of
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Source: CytomX Therapeutics Inc.