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February 4, 2021

LoA Update: Beijing Sunbio Biotech’s Phase III RRMM asset sees 18–19 point increase for US approval chances

As of 6 January, the likelihood of approval (LoA) for Beijing Sunbio Biotech’s Phase III drug for relapsed and refractory multiple myeloma rose 18–19 points, according to GlobalData’s LoA data.

By GlobalData Healthcare

As of 6 January, the likelihood of approval (LoA) for Beijing Sunbio Biotech’s Phase III drug for relapsed and refractory multiple myeloma rose 18–19 points, according to GlobalData’s LoA data.

The score change was based on results provided during the American Society of Hematology (ASH) annual meeting held last December.

On 6 December 2020, the company showcased Phase III relapsed or refractory multiple myeloma trial results, noting that circularly permuted TRAIL (CPT) was an effective drug when combined with thalidomide and dexamethasone (TD), including among patients who had previously received multiple lines of treatment, and those who were refractory to proteasome inhibitors (PI) and immunomodulators (IMIDs).

CPT, a recombinant permuted human TNF-related apoptosis-inducing ligand (TRAIL), targets death receptor 4/5.

LoA up, but no disclosure on US New Drug Application intention

While the LoA by the FDA prior to this news was 25–26%, GlobalData’s analysis using a combination of machine learning and a proprietary algorithm has notched up the LoA to 43–45%. The company has not disclosed whether it intends to file a US NDA.

According to the paper published on the ASH website, out of 415 patients in the trial, 276 received CPT/TD and 139 were in the TD-alone arm; the median number of lines of previous treatment was three; and PI and IMID were previously used in 74% and 86.5% of patients, respectively.

At data cutoff, the primary endpoint of media progression-free survival was 5.5 versus 3.1 months in the treatment and comparator groups, respectively (hazard ratio 0.619; p < 0.0001). Key secondary endpoints of overall response rate (30.4% versus 13.7%, p = 0.0002) and median overall survival (21.8 versus 17.0 months; HR 0.723; p = 0.0166) were also improved.

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