publication date: Nov. 8, 2019

Clinical Roundup

Phase III trial of Ninlaro as first-line maintenance therapy meets PFS in multiple myeloma

The phase III Takeda TOURMALINE-MM4 study met its primary endpoint of progression-free survival in multiple myeloma not treated with stem cell transplantation.

The trial evaluated the effect of single-agent oral Ninlaro (ixazomib) as a first-line maintenance therapy versus placebo, and demonstrated statistically significant improvement in PFS, according to Takeda. TOURMALINE-MM4 is the first industry-sponsored phase III trial to explore the concept of “switch” maintenance, the use of medicines not included in initial induction therapy, in this setting.

Ninlaro is not approved for this specific use.

TOURMALINE-MM4 is a randomized, placebo-controlled, double-blind phase III study of 706 patients who have completed 6-12 months of initial therapy and achieved a partial response or better.


Inovio demonstrates 80% 6-month PFS in phase II glioblastoma multiforme study with INO-5401 + Libtayo

A phase II study (NCT03491683) of newly diagnosed glioblastoma multiforme combining Inovio’s INO-5401 and INO-9012 in combination with Libtayo (cemiplimab) showed that 80% (16 of 20) of MGMT gene promoter methylated patients and 75% (24 of 32) of unmethylated patients were progression-free at six months measured from the time of their first dose (n = 52), substantially exceeding historical standard-of-care data.

INO-5401 is a T cell-activating immunotherapy encoding for three tumor-associated antigens (hTERT, WT1, and PSMA). INO-9012 is an immune activator encoding IL-12, and Libtayo is a PD-1 blocking antibody developed by Regeneron Pharmaceuticals in collaboration with Sanofi.

The data were to be presented at the Society for Immunotherapy of Cancer 2019 Annual Meeting in National Harbor, MD, Nov. 6-10.

This immunotherapy combination with a … Continue reading Phase III trial of Ninlaro as first-line maintenance therapy meets PFS in multiple myeloma

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