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June 11, 2021

LoA Update: Sanofi’s KY1044 approval chances jumps by 21 points after Phase I/II ASCO data reveal in triple-negative breast cancer

Sanofi’s KY1044 Likelihood of Approval (LoA) in triple-negative breast cancer (TNBC) jumped by 21 points on the back of positive data reported at this weekend’s virtual ASCO meeting.

By Reynald Castañeda

Sanofi’s KY1044 Likelihood of Approval (LoA) in triple-negative breast cancer (TNBC) jumped by 21 points on the back of positive data reported at this weekend’s virtual ASCO meeting. In a Phase I/II basket trial, one complete response was reported in a TNBC patient and another having partial response (abstract no 2624).

The Phase I/II is investigating KY1044 as a monotherapy and in combination with Roche’s Tecentriq (atezolizumab), with a primary endpoint looking at safety and maximum tolerated dose. At ASCO, partial response was also reported in one of each patient having head and neck squamous cell carcinoma, penile and pancreatic cancer. KY1044 previously had an LoA of 4%, rising to 25%, as of 7 June.

Meanwhile, Sanofi’s Phase IIa KY1044 had its LoA increase by 5 points in moderate-to-severe atopic dermatitis after its ClinicalTrial.gov page was updated on 30 April. The Phase IIa trial listing was updated, particularly the total number of patients increasing from 88 to 89 patients. Although the trial is listed as completed, it is yet to report data. KY1005 previously had an LoA of 26%, increasing to 31%, as of 7 June.

KY1044 and KY1044 were initially developed by Cambridge, UK-based Kymab before it was acquired by Sanofi on 11 January, with a $1.1bn upfront payment, plus $350m once certain milestones are met.

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.

Sanofi has a market cap of $110.91bn.

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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.

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