Innovent’s LoA for Tyvyt in metastatic melanoma drops by 4 points
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LoA Update: Innovent’s approval likelihood for Tyvyt in metastatic melanoma drops by 4 points after completion of Phase Ib basket trial

By Reynald Castaneda 08 Jun 2021 (Last Updated June 8th, 2021 13:44)

Innovent Biologics’ Tyvyt (sintilimab) had its Likelihood of Approval (LoA) decrease by four points in metastatic melanoma after the Phase Ib basket trial’s ClinicalTrial.gov status was updated to completed on 6 May.

LoA Update: Innovent’s approval likelihood for Tyvyt in metastatic melanoma drops by 4 points after completion of Phase Ib basket trial
Tyvyt is still in an ongoing 300-patient Phase III trial studying Tyvyt plus anti an CTLA-4 inhibitor in acral melanoma in the adjuvant setting. Credits: David A Litman/Shutterstock.com.

Innovent Biologics’ Tyvyt (sintilimab) had its Likelihood of Approval (LoA) decrease by four points in metastatic melanoma after the Phase Ib basket trial’s ClinicalTrial.gov status was updated to completed on 6 May. Tyvyt previously had an LoA of 13%, which dropped to 9%, as of 2 June.

Data from the 39-patient Phase Ib basket trial investigating Tyvyt monotherapy, which recruited first-line or second-line melanoma, is yet to be reported. Tyvyt is still in an ongoing 300-patient Phase III trial studying Tyvyt plus anti an CTLA-4 inhibitor in acral melanoma in the adjuvant setting. Tyvyt is an anti-PD1 therapy.

Innovent is working with Eli Lilly to develop Tyvyt in multiple cancer indications. On 18 May, both companies announced the FDA has accepted their BLA application for Tyvyt in first-line nonsquamous non-small cell cancer (NSCLC), the first US regulatory submission for the asset. Tyvyt is already approved in China in Hodgkin’s lymphoma and NSCLC.

LoA is identified via GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. LoA is calculated by compounding the Phase Transition Success Rate (PTSR) at each stage the drug is yet to progress through. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next. Both LoA and PTSR can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.

Innovent has a $16.7bn market cap, while Lilly’s is $212.3bn.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.