GSK's pazopanib shines in Phase III kidney cancer trial
03 June 2009
GlaxoSmithKline has presented promising late-stage data on its investigational oral oncology agent pazopanib which demonstrates that the drug reduced the risk of tumour progression or death by 54% in advanced kidney cancer patients compared to placebo.
Data presented at the American Society for Clinical Oncology meeting in Orlando showed the median progression free survival (PFS), the time without tumour growth or death, for patients on pazopanib was 9.2 months compared with 4.2 months for those on placebo. The Phase III, 435-patient trial also revealed that those with no prior drug treatment experienced 11.1 months of PFS with pazopanib versus 2.8 months with placebo, while patients who had been on cytokine-based treatment showed 7.4 months of median PFS with pazopanib versus 4.2 months with placebo.
The GSK quoted Cora Sternberg of the San Camillo and Forlanini Hospitals in Rome, as saying that the study shows that pazopanib significantly improved PFS for patients “regardless of whether or not they had prior therapy”. She added that while there have been many treatment advances for patients with advanced kidney cancer, “there is still a need for medicines that are effective and well-tolerated”. Dr Sternberg concluded by noting that patients did not experience a significant decline in health-related quality of life with no significant differences between pazopanib and placebo.
Pazopanib, a once-daily angiogenesis inhibitor, was filed with the US Food and Drug Administration in December and with Euriopean regulators at the beginning of 2009. Paolo Paoletti at GSK’s R&D Oncology Unit noted that apart from advanced kidney cancer, “our global studies using pazopanib are designed to find new ways to use a proven mechanism to fight a diverse group of cancers”.
Arzerra recommended for CLL
Meantime, GSK and partner Genmab have been celebrating the news that the FDA’s Oncology Drug Advisory Committee has recommended approval for the firms’ Arzerra (ofatumumab) as a treatment for chronic lymphocytic leukaemia.
Despite concerns expressed by staffers at the FDA, the committee voted 10-3 about the clinical benefit of Arzerra for patients with CLL whose disease is refractory to fludarabine and alemtuzumab, a move which fuelled a leap in the Danish drugmaker’s share price.
By Kevin Grogan
03 June 2009
GlaxoSmithKline has presented promising late-stage data on its investigational oral oncology agent pazopanib which demonstrates that the drug reduced the risk of tumour progression or death by 54% in advanced kidney cancer patients compared to placebo.
Data presented at the American Society for Clinical Oncology meeting in Orlando showed the median progression free survival (PFS), the time without tumour growth or death, for patients on pazopanib was 9.2 months compared with 4.2 months for those on placebo. The Phase III, 435-patient trial also revealed that those with no prior drug treatment experienced 11.1 months of PFS with pazopanib versus 2.8 months with placebo, while patients who had been on cytokine-based treatment showed 7.4 months of median PFS with pazopanib versus 4.2 months with placebo.
The GSK quoted Cora Sternberg of the San Camillo and Forlanini Hospitals in Rome, as saying that the study shows that pazopanib significantly improved PFS for patients “regardless of whether or not they had prior therapy”. She added that while there have been many treatment advances for patients with advanced kidney cancer, “there is still a need for medicines that are effective and well-tolerated”. Dr Sternberg concluded by noting that patients did not experience a significant decline in health-related quality of life with no significant differences between pazopanib and placebo.
Pazopanib, a once-daily angiogenesis inhibitor, was filed with the US Food and Drug Administration in December and with Euriopean regulators at the beginning of 2009. Paolo Paoletti at GSK’s R&D Oncology Unit noted that apart from advanced kidney cancer, “our global studies using pazopanib are designed to find new ways to use a proven mechanism to fight a diverse group of cancers”.
Arzerra recommended for CLL
Meantime, GSK and partner Genmab have been celebrating the news that the FDA’s Oncology Drug Advisory Committee has recommended approval for the firms’ Arzerra (ofatumumab) as a treatment for chronic lymphocytic leukaemia.
Despite concerns expressed by staffers at the FDA, the committee voted 10-3 about the clinical benefit of Arzerra for patients with CLL whose disease is refractory to fludarabine and alemtuzumab, a move which fuelled a leap in the Danish drugmaker’s share price.
By Kevin Grogan
3/6 2009 19:09 tumult 0
12803 Ok, det var så ikke så meget nyt om Genmab.
Undskyld jeg var lidt for hurtig.
Undskyld jeg var lidt for hurtig.
3/6 2009 20:39 tumult 012811 Det har dette sådan set heller ikke, men hvis Carl Icahn er vred på
Biogen kan han bare sælge og købe Genmab.
An angry Carl Icahn said Wednesday Biogen Idec Inc. (BIIB) is acting in its
usual shareholder unfriendly way in recessing its annual meeting to extend the
voting time for directors by several hours.
The billionaire investor has nominated four people to the Cambridge, Mass.,
biotech companys 13-member board as part of his ongoing effort to shake up the
companys direction.
In a statement, Icahn said Biogen shareholders should demand that this board
finally act in their interest instead of just attempting to re-elect
themselves. The company is allowing shareholders until 2 p.m. EDT to finish
casting their votes.
The recess was made over shouted objections from Icahns nominees, who called
the move an improper manipulation of the companys voting process. In response,
Chairman Bruce Ross said, I have authority to declare a recess.
Biogen had said it would close its polls and count votes starting at 9 a.m.
EDT. The adjournment suggests Icahn is within striking distance of winning at
least some seats.
Icahns fight is backed by an influential proxy adviser and, observers
believe, by Biogens largest shareholders. But the New York billionaire - who
flopped in an initial effort last year - faces an uphill battle to persuade
smaller shareholders that he could revive the drug makers stagnant shares,
analysts said.
Biogen shares were recently up 3.5 at $54.15.
Biogen kan han bare sælge og købe Genmab.
An angry Carl Icahn said Wednesday Biogen Idec Inc. (BIIB) is acting in its
usual shareholder unfriendly way in recessing its annual meeting to extend the
voting time for directors by several hours.
The billionaire investor has nominated four people to the Cambridge, Mass.,
biotech companys 13-member board as part of his ongoing effort to shake up the
companys direction.
In a statement, Icahn said Biogen shareholders should demand that this board
finally act in their interest instead of just attempting to re-elect
themselves. The company is allowing shareholders until 2 p.m. EDT to finish
casting their votes.
The recess was made over shouted objections from Icahns nominees, who called
the move an improper manipulation of the companys voting process. In response,
Chairman Bruce Ross said, I have authority to declare a recess.
Biogen had said it would close its polls and count votes starting at 9 a.m.
EDT. The adjournment suggests Icahn is within striking distance of winning at
least some seats.
Icahns fight is backed by an influential proxy adviser and, observers
believe, by Biogens largest shareholders. But the New York billionaire - who
flopped in an initial effort last year - faces an uphill battle to persuade
smaller shareholders that he could revive the drug makers stagnant shares,
analysts said.
Biogen shares were recently up 3.5 at $54.15.
