PharmaEngine : Phase III RESILIENT trial evaluating Onivyde in second-line monotherapy for small cell lung cancer did not meet its primary endpoint

 Phase III RESILIENT trial evaluating Onivyde
in second-line monotherapy for small cell lung cancer
did not meet its primary endpoint

1.Date of occurrence of the event:2022/08/03
2.Company name:PharmaEngine Inc
3.Relationship to the Company (please enter "head office" or
  "subsidiaries"):head office
4.Reciprocal shareholding ratios:NA
5.Cause of occurrence:
Trial Design:
RESILIENT is a randomized, 1:1, open-label Phase III trial of Onivyde
(irinotecan liposome IV injection) versus IV topotecan in 450 patients
 enrolled with small cell lung cancer who have progressed on or after
platinum-based first line therapy.
The primary outcome measure is OS. Secondary outcome measures include
progression-free survival, objective response rate. Safety analyses
(adverse events and laboratory analyses) will be performed using the
safety population, defined as all patients receiving any trial medicine.
Outcome analysis
According to IPSEN's official press release, the analysis concluded
that the primary endpoint OS was not met in patients treated with
Onivyde versus topotecan. However, a doubling of the secondary endpoint
 of objective response rate (ORR) in favor of Onivyde was observed.
The safety and tolerability of Onivyde was consistent with its already
 known safety profile, and no new safety concerns emerged. Detailed
results from the RESILIENT trial will be presented at an upcoming
medical conference by IPSEN.
Market situation: The clinical study results will be communicated
with the regulatory agency by IPSEN.
New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks. The investors
are advised to exercise caution and conduct thorough evaluation.
6.Countermeasures:NA
7.Any other matters that need to be specified:
ONIVYDE was authorized to Merrimack USA in May, 2011. However, Merrimack
 USA sold the products to IPSEN in Apr. 2017. Currently, IPSEN has
finished worldwide phase III human subject clinical trials for first-line
 pancreatic cancer and second-line small cell lung cancer.
All development expenses for worldwide phase III human subject clinical
trials for first-line pancreatic cancer and second-line small cell lung
cancer are paid for by IPSEN.
All clinical trial outcome/results would be informed by IPSEN, and
PharmaEngine would upload those information to the MOPS.
The outcome of RESILIENT trial won't impact the global sales of
OnivydeR on 2L PDAC.