Latest update from Jefferies Healthcare Conference
Alright, if you've been following, what has changed from April corporate update to yesterday update at Jefferies?
Before I post the latest update, for context, here are the registration studies for the two currently approved agents for relapse/refractory T-cell lymphoma (R/R TCL) and some common terminology: ORR or objective response rate means partial response + complete response (PR+CR); progression free survival (PFS); absolute lymphocyte count (ALC) per microliter. Remember that in this aggressive disease, many patients don't even make it to the first evaluation period (for CPI-181, that is 3-month of treatment) since they have about 3 prior treatments before taking CPI-818. So, it is critical to illustrate the activity of CPI-818 to include less sick patients, where their ALC is still normal (>1000).
-pralatrexate (in 111 patients): ORR of 29% (with CR of 11%), PFS of 3.5 months
-belinostat (in 129 patients): ORR of 25.6% (with CR of 10.6%), PFS of 8.4 months
April 2023, Corvus reported for CPI-818 (13 evaluable patients, with n = 8 patients meeting Corvus biomarker criterion of ALC>900, data cutoff as of February 20223): ORR of 4/8 or 50% (with 3/8 or 37.5% CR), PFS of 28.1 months; for patients not meeting their biomarker criterion or ALC<900): ORR of 0/5 or 0% (with 0/5 or 0% CR); PFS of 2.1 months
June 7, 2023 Jefferies conference, Corvus reported for CPI-818 (19 evaluable patients, with n = 13 patients meeting Corvus biomarker criterion of ALC>900, data cutoff as of May 1,2023): ORR of 6/13 or 46.2% (with 3/13 or 23% CR), PFS of 19.9 months; for patients not meeting their biomarker criterion or ALC<900): ORR of 0/6 or 0% (with 0/6 or 0% CR); PFS of 2.1 months
The data that will be presented next week June 13th at the iCML in Lugano, Switzerland won't be much different from the June 7, 2023 presentation; maybe a couple more evaluable patients will be included and some of the stable disease patients could convert into PR or PR into CR, but that's it. It won't materially change the ORR and PFS from yesterday's presentation.
Richard Miller (Corvus' CEO) also further clarified on their planned registrational phase 3 study for CPI-818 in R/R TCL (Richard expects to meet and conclude meeting with the FDA before August 2023) that will also enroll less sick patients (with one and three treatments; to take advantage of CPI-818 mechanism of action of skewing toward Th1). The trial will be 1 to 1 randomized study with 75 patients in CPI-818 and 75 patients with the physician's choice of either pralatrexate, belinostat or gemcitabine (which is not an approved drug, but it's an old drug and oncologists used it more than pralatrexate plus belinostat combined), with PFS as the primary endpoint; with PFS in the comparator arm (pralatrexate, belinostat or gemcitabine) expecting to be about 3 months, the trial will be completed and NDA filed in 2.5 years from end of this year.
