Human Trials

FDA accepts Cellenkos’ IND to begin clinical trial of CK0801 for bone marrow failure syndromes

The US Food and Drug Administration (FDA) has cleared Cellenkos’ investigational new drug (IND) application to proceed with a phase I clinical trial of CK0801, third party cord blood derived regulatory T cells, in patients with bone marrow failure syndrome including aplastic anemia, myelodysplastic syndrome and myelofibrosis.

Alnylam’s Lumasiran yields positive results in phase 1/2 Hyperoxaluria study

Alnylam Pharmaceuticals said that lumasiran, its investigational RNAi therapeutic targeting glycolate oxidase (GO) has yielded positive results from a phase 1/2 study in patients with Primary Hyperoxaluria Type 1 (PH1).

AbbVie’s upadacitinib succeeds in phase 3 trial in rheumatoid arthritis

AbbVie said that the phase 3 SELECT-EARLY trial evaluating two doses of upadacitinib (15 mg and 30 mg) as monotherapy in the treatment of rheumatoid arthritis met the primary endpoints of ACR50a at week 12 and clinical remissionb at week 24 versus methotrexate (MTX).

AstraZeneca says Lynparza/abiraterone combo delayed disease progression in mCRPC

AstraZeneca has reported that Lynparza (olaparib) in combination with abiraterone succeeded in a phase II trial by delaying disease progression in metastatic castration-resistant prostate cancer (mCRPC) patients.

Novartis phase III trial shows Kisqali combo therapy improves PFS in HR+/HER2- advanced breast cancer

Novartis has reported positive results from the third Phase III trial of Kisqali (ribociclib) in advanced or metastatic breast cancer.

Syndax, Nektar Therapeutics announce immuno-oncology clinical trial collaboration

Syndax Pharmaceuticals and Nektar Therapeutics have entered into a non-exclusive immuno-oncology clinical trial collaboration.

Trial to test cancer combo in adults and children with leukaemia

The Combinations Alliance, a joint initiative between Cancer Research UK and the Experimental Cancer Medicine Centres (ECMC) Network based at University of Birmingham, has launched a clinical trial testing a new treatment combination in patients with leukaemia.

Janssen begins phase 1b/2 clinical trial to assess multiple myeloma treatment

Janssen has commenced a phase 1b/2 clinical development program to assess JNJ-68284528 (developed based on Legend’s LCAR-B38M), a chimeric antigen receptor T cell (CAR-T) therapy directed against B cell maturation antigen (BCMA), in patients with relapsed or refractory multiple myeloma.

Roche’s Tecentriq-chemo combo extends survival in phase 3 NSCLC trial

Roche said that its cancer immunotherapy Tecentriq (atezolizumab) in combination with chemotherapy as first-line of treatment improved survival of patients with advanced non-squamous non-small cell lung cancer (NSCLC) in a phase 3 trial.