dm+d

Unassigned

New Medicines

Unresectable or metastatic malignant melanoma - first-line in combination with nivolumab

Information

New molecular entity
Bristol-Myers Squibb
Bristol-Myers Squibb and Nektar Therapeutics

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Apr 22Bristol Myers and Nektar decide to discontinue all studies of the drug combination after another 2 late stage trials fail, following PIII PIVOT IO-001 [10].

Category

CD122-biased agonist designed to stimulate the patient immune system to fight cancer. It allows the growth of specific cancer-killing T-cells (CD+8) and natural killer (NK) cells which are known as endogenous tumour-infiltrating lymphocytes (TILs).
In 2011, the UK age-standardised incidence of melanoma for females was 17.6 (11.7 in 2001) and for males 17.5 (10.1 in 2001) per 100,000 population [1].
Unresectable or metastatic malignant melanoma - first-line in combination with nivolumab
Intravenous infusion

Further information

Yes

Trial or other data

Mar 22Company announces PIII PIVOT IO-001 (NCT03635983) did not reach its primary endpoints of progression-free survival and objective response rate. No benefit of dual therapy vs nivolumab was shown [9].

Evidence based evaluations

Advanced renal cell carcinoma - first-line with nivolumab

Information

New molecular entity
Bristol-Myers Squibb
Bristol-Myers Squibb and Nektar Therapeutics

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Apr 22Bristol Myers and Nektar decide to discontinue all studies of the drug combination [6].

Category

CD122-biased agonist designed to stimulate the patient immune system to fight cancer. It allows the growth of specific cancer-killing T-cells (CD+8) and natural killer (NK) cells which are known as endogenous tumour-infiltrating lymphocytes (TILs).
UK incidence of RCC is 12 per 100,000 people. Patients with stage 1 (39%) and 2 (16%) RCC, and some with stage 3 (26%), are candidates for surgery. Five-year survival ranges from 40-90% in stage 1-3 disease, and 10% in stage 4.
Advanced renal cell carcinoma - first-line with nivolumab
Intravenous infusion

Trial or other data

Apr 22BMS and Nektar announce that a preplanned interim analysis of PIII study (NCT03729245) found the investigational combination failed to improve on the overall survival achieved by the TKIs in either population. The companies have decided to unblind the trial and perform no more overall survival analyses [6].