dm+d

Unassigned

New Medicines

Advanced cutaneous squamous cell carcinoma (cSCC) - in combination with cemiplimab

Information

New molecular entity
Replimune
Replimune

Development and Regulatory status

None
None
Phase II Clinical Trials
Nov 20Replimune believes data the CERPASS trial could support a filing with regulatory authorities for marketing approval, and expects primary data read-out in 2022. Although based in the US, Replimune has significant research and development operations in the UK, and source third-party manufacturing, consulting and other services in the UK and the European Union [5].

Category

Oncolytic immunotherapy based on a new strain of herpes simplex virus, engineered for tumour selectivity & enhanced systemic potency, through the expression of a potent fusogenic glycoprotein from gibbon ape leukemia virus (GALV-GP R) and GM-CSF.
Incidence of SCC is about 10,000 per year in England and Wales. The incidence is higher in Caucasians [1].
Advanced cutaneous squamous cell carcinoma (cSCC) - in combination with cemiplimab
Intratumoural

Trial or other data

Oct 20PII CERPASS and PI/II NCT03767348 trial are both recruiting and due to complete collection of primary outcome data in Oct 22 and Nov 21, respectively [3].
Jun 20Interim data from the PII part of a PI/II trial (NCT03767348) released by Replimune. RPL-001-16 is an open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy. Overall, four of seven evaluable patients have ongoing CRs and six of seven have an ongoing CR or partial response (PR) (compared to one out of five patients and two out of five, respectively, as presented at the Society for the Immunotherapy of Cancer meeting in November 2019). The data continues to demonstrate that RP1 in combination with Opdivo is well-tolerated, demonstrates immune activation and continues to drive deep and durable responses in patients with CSCC. Furthermore, the number of CRs observed to date in advanced CSCC patients with aggressive disease treated with RP1 in combination with anti-PD-1 provides clear differentiation versus anti-PD-1 therapy alone, which we believe provides the Company strong validation of its clinical development plan. PII CERPASS is the registration-directed clinical trial [4].
Oct 19PII CERPASS trial to evaluate the efficacy of RP 1 in combination with cemiplimab in patients with locally advanced or metastatic cSCC starts (RPL-002-18; NCT04050436). 240 adults will be recruited in Australia and the US. Primary outcome is objective response rate; collection of these data is due to complete Oct 22 [2].