Clinical Trials

Kisqali, fulvestrant combo meets overall survival endpoint in MONALEESA-3

Novartis said that its CDK4/6 inhibitor Kisqali (ribociclib) in combination with fulvestrant could deliver a statistically significant improvement in overall survival in a phase 3 trial, called MONALEESA-3.

SpringWorks gets EC orphan drug designation for NF1 treatment mirdametinib

SpringWorks Therapeutics has secured orphan drug designation from the European Commission (EC) for its mirdametinib to treat neurofibromatosis type 1 (NF1).

Lilly’s Verzenio plus fulvestrant improves overall survival in MONARCH 2

Eli Lilly and Company (Lilly) said that Verzenio (abemaciclib) in combination with fulvestrant significantly extended life in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in a phase 3 trial.

Keytruda plus chemotherapy meets co-primary endpoint in KEYNOTE-522 trial

Merck said that Keytruda in combination with chemotherapy has met one of the two primary endpoints of a phase 3 trial in triple-negative breast cancer (TNBC).

ViiV Healthcare announces positive week 48 results from TANGO study of dolutegravir/lamivudine

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that data from the phase III TANGO study showed that the 2-drug regimen (2DR) of Dovato (dolutegravir/lamivudine) has similar efficacy to a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs in virally supressed and stable adults with HIV-1.

BMS announces mixed results of lung cancer drug Opdivo

Bristol-Myers Squibb (BMS) has announced the mixed results from the phase 3 CheckMate -227 trial of the lung cancer drug Opdivo (nivolumab).

ViiV’s fostemsavir yields positive week 96 results in phase 3 HIV-1 trial

ViiV Healthcare said that a phase 3 trial of fostemsavir in heavily treatment-experienced adults with HIV-1 infection has yielded positive results after 96 weeks of treatment.

ACADIA announces top-line results from phase 3 schizophrenia trial of Pimavanserin

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), today announced top-line results from its Phase 3 ENHANCE study, which evaluated pimavanserin as an adjunctive treatment in adult schizophrenia patients with persistent inadequate response to their current antipsychotic therapy.

Sandoz recruits first patient in clinical study for proposed biosimilar denosumab in osteoporosis

Sandoz, a Novartis division and a global leader in biosimilars, announced the first patient enrolled in ROSALIA, an integrated Phase I/III clinical study for its proposed biosimilar denosumab.