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New drug applications approved by US FDA as of 16 - 31 May 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
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Ramucirumab combined with docetaxel outperforms chemotherapy alone for advanced bladder cancer

Dr. Joseph Delano Fule Robles
15 Sep 2017

Combination therapy with ramucirumab and docetaxel offers a progression-free survival (PFS) advantage over docetaxel alone in patients with advanced or metastatic urothelial carcinoma (UC), according to results of the phase III RANGE trial presented at the European Society of Medical Oncology  (ESMO) 2017 Congress held in Madrid, Spain.

The randomized, double-blind, international, multicentre trial included 530 patients with advanced or metastatic UC who progressed during or after platinum-based chemotherapy. A significant 24.3 percent improvement in PFS was shown in patients who received ramucirumab plus docetaxel vs placebo plus docetaxel (median, 4.07 vs 2.76 months; hazard ratio [HR], 0.757; p=0.0118). [Lancet 2017, doi: http://dx.doi.org/10.1016/S0140-6736(17)32365-6]

Investigator assessment of the PFS outcomes were also consistent among most patient subgroups.

Best overall response rate (24.5 vs 14 percent), complete (4.2 vs 1.4 percent) and partial (20.4 vs 12.7 percent) response rates were also higher among patients who received ramucirumab plus docetaxel vs placebo plus docetaxel.

The frequency of grade ≥3 adverse events were similar between the two groups (ramucirumab group, 60 percent; placebo group, 62 percent). The most common grade 3 adverse events with ramucirumab plus docetaxel were neutropenia (15 percent), febrile neutropenia (10 percent), fatigue (8 percent) and leukopenia (7 percent). In the placebo plus docetaxel group, the most common grade 3 adverse events were neutropenia (14 percent), anaemia (11 percent), fatigue (9 percent) and leukopenia (8 percent).

Mean scores for global quality of life were similar between the two groups, with no significant difference in time to sustained deterioration in global quality of life (non-stratified HR, 0.931; p=0.610).

“Ramucirumab plus docetaxel could become a new treatment option for patients with platinum-refractory advanced UC… The combination therapy did not result in significant additive toxicity or compromise quality of life when compared with placebo plus docetaxel,” said investigator Professor Daniel Petrylak of the Yale University School of Medicine, New Haven, Connecticut, US.  

“The strengths of the study are its ability to meet its primary endpoint, with best ORR reported in a phase III trial in unselected patients along with manageable side effects in this group of complex and frail patients,” commented discussant Dr Yohann Loriot of the Gustave Roussy, University of Paris Saclay, Villejuif, France.

“However, with only 10 percent of patients in the study having received prior immune checkpoint inhibitor [ICI] therapy, the question now is whether ramucirumab plus docetaxel will be active in patients in whom ICIs have no activity or whether ICIs would induce hyperprogression,” argued Loriot.

The overall survival data from this study was not presented due to immaturity. The data are expected to be reported in a separate interim analysis.

The RANGE trial was conducted as a follow-up on the successful phase II study in patients with platinum-refractory advanced or metastatic UC, which showed significant improvement in PFS with ramucirumab plus docetaxel compared with docetaxel alone (median, 5.4 vs 2.8 months; HR, 0.389; p=0.0002).[J Clin Oncol 2016;34:1500-1509]

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Most Read Articles
Rachel Soon, 26 Jun 2018

MIMS Pharmacist presents an overview of phosphatidylcholine's physiological role, as well as contemporary research on its pharmacology and effects.

17 Mar 2018
Nonvitamin K antagonist oral anticoagulants (NOAC)-associated intracerebral haemorrhage (ICH) and vitamin K antagonists-ICH appear to have similar ICH volume, haematoma expansion, functional outcome and mortality, results of a recent meta-analysis have shown.
31 May 2017
New drug applications approved by US FDA as of 16 - 31 May 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
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