SillaJen Submits CSR to the US FDA for REN026 Study in Patients with RCC
The study demonstrated an acceptable safety profile and encouraging efficacy of the combination therapy of Pexa-Vec, an engineered oncolytic vaccinia virus, and Libtayo (cemiplimab), anti-PD-1 monoclonal antibody developed by
In 2017,
Following the
The study was conducted in four study arms (A to D) to assess the safety and efficacy of the Pexa-Vec in combination with cemiplimab.
In Arm C, consisting of patients naïve to Immune checkpoint inhibitors (ICIs), Pexa-Vec in combination with cemiplimab showed the overall response rate (ORR) of 23.3% and the median overall survival (OS) of 25.13 months. Both ORR and OS were the highest compared to other study arms.
In Arm D, patients with prior ICI treatment demonstrated ORR of 17.9 %, the second highest of the four arms.
In particular, Arm D included 22 out of 28 patients (78.57%) with the three or more prior systemic regimens in metastatic setting and 5 patients (17.86%) with two prior treatments. Given the typically lower response rates in patients with more prior extensive treatments, the results are considered highly encouraging.
About REN026
1) Background
Pexa-vec (PV) is an oncolytic and immunotherapeutic vaccinia virus engineered to express GM-CSF. The REN026 study assessed the antitumor activity and safety of intravenous (IV) or intratumoral (IT) PV in combination with cemiplimab, anti-PD-1monoclonal antibody, in patients with metastatic or unresectable renal cell carcinoma (RCC).
2) Methods
The study enrolled 95 patients in total, including 6 patients in dose-escalation phase and 89 patients with measurable histologically or cytologically confirmed metastatic or unresectable RCC were randomly assigned to one of four study arms.
Patients naïve to immune checkpoint inhibitors (ICIs) with accessible tumors were randomized into Arm A (IT PV and cemiplimab) or Arm B (cemiplimab monotherapy, addition of IT PV upon disease progression).
Patients naïve to ICIs with non-accessible tumors were placed in Arm C with IV PV and cemiplimab, and those with prior ICIs treatment were assigned to Arm D with IV PV and cemiplimab.
PV was given IT (Arms A and B) administered every 2 weeks or IV (Arms C and D) weekly for 3 or 4 treatments as 1× 109 pfu. cemiplimab IV infusion (all study arms) was administered every 3 weeks, at a dose of 350 mg.
3) Results
Between
The overall response rate (by RECIST 1.1) across the arms were as follows: Arm A – 13.3% (2PR), Arm B – 12.5% (2 PR), Arm C – 23.3% (1 CR, 6 PR) and Arm D – 17.9% (5 PR).
Median progression-free survival and overall survival for the arms were 4.27/22.0 months, 5.65/20.8 months, 4.57/25.1 months and 6.31/18.5 months, respectively.
All patients experienced treatment-related AEs (any grade); 40 (45.5 %) experienced a grade 3 or 4 event.
Pyrexia was the most common treatment-related AE.
No Grade 5 events occurred in any of the study arms.
4) Summary of efficacy results
A (n=15) |
B (n=16) |
C (n=30) |
D (n=28) |
|
ORR (95% CI)-% |
13.3 (1.7-40.5) |
12.5 (1.6-38.3) |
23.3 (9.9-42.3) |
17.9 (6.06-36.9) |
DCR (95% CI)-% |
60.0 (32.3-83.7) |
56.3 (29.9-80.2) |
63.3 (43.9-80.1) |
67.9 (47.6-84.1) |
PFS median (mo) (80% CI) |
4.27 (2.37-NR) |
5.65 (2.07-NR) |
4.57 (4.34-15.44) |
6.31 (3.29-NR) |
OS median (mo) (80% CI) |
21.98 (21.98-NR) |
20.83 (19.52-NR) |
25.13 (22.01-NR) |
18.53 (14.75-NR) |
5) Conclusions
The combination of IV Pexa-Vec and cemiplimab demonstrated an acceptable safety profile and encouraging efficacy of ORR and survival with durable responses in patients with metastatic or unresectable RCC, regardless of previous ICI treatment.
About Pexa-Vec and the SOLVE Platform
Pexa-Vec is SillaJen’s representative investigational product from the company’s proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. 595 cancer patients have been treated with Pexa-Vec as of
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