Spexotras
Oncology· 797 cited findings· 1 source document
Company: Novartis AG →
What the regulatory reviews say
Spexotras is a drug that received a positive opinion for marketing authorization on 9 November 2023, following a centralized procedure. It has been granted Orphan medicinal product designation (EU/3/20/2374).
In the LGG cohort, the overall response rate (ORR) for the D+T arm was 46.6%, compared to 10.8% for the C+V arm, with an odds ratio of 7.19 (p-value <0.001). The median progression-free survival (PFS) was 20.1 months in the D+T arm versus 7.4 months in the C+V arm, with a hazard ratio of 0.31. For the HGG cohort, the ORR at interim analysis was 37.5%. The estimated overall survival rates at 12 months were 76.3%.
Regarding safety, 98.8% of patients in the combination therapy pool experienced at least one adverse event (AE), with 57.3% experiencing Grade ≥3 AEs. AEs led to treatment discontinuation in 7.6% of patients in the combination therapy pool. In the LGG cohort, 46.6% of patients in the D+T arm experienced grade ≥3 AEs, while 87.9% in the C+V arm experienced grade ≥3 AEs suspected to be study treatment related.
Key figures — cited to the source page
| ORR (LGG cohort, D+T arm) | 46.6 | Novartis AG — Spexotras EMA EPAR public assessment report (E, p.73 |
| ORR (LGG cohort, C+V arm) | 10.8 | Novartis AG — Spexotras EMA EPAR public assessment report (E, p.73 |
| odds ratio for ORR (LGG cohort, D+T vs C+V) | 7.19 | Novartis AG — Spexotras EMA EPAR public assessment report (E, p.73 |
| median PFS (LGG cohort, D+T arm) | 20.1 | Novartis AG — Spexotras EMA EPAR public assessment report (E, p.74 |
| median PFS (LGG cohort, C+V arm) | 7.4 | Novartis AG — Spexotras EMA EPAR public assessment report (E, p.74 |
| HR for PFS (LGG cohort, D+T vs C+V) | 0.31 | Novartis AG — Spexotras EMA EPAR public assessment report (E, p.74 |
| patients with Grade ≥3 AEs (combination therapy pool) | 57.3 | Novartis AG — Spexotras EMA EPAR public assessment report (E, p.98 |
| Marketing authorization positive opinion date | 9 November 2023 | Novartis AG — Spexotras EMA EPAR public assessment report (E, p.9 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.