News

GA101 succeeds in Phase III
Enlarge image

BusinessSwitzerland

GA101 succeeds in Phase III

17.05.2013 - Roche’s glyco-optimised anti-CD20 antibody obinutuzumab (GA101) significantly reduced the risk of disease in patients with leukaemia (CCL).

According to the first results from Roche/Genentech’s Phase III-CLL11, GA101 plus chlorambucil therapy more than doubled progression-free survival (PFS) of treatment-native chronic lymphocytic leukaemia  (CCL) patients (23 months compared to 10.9 months, HR=0.14, 95% CI 0.09-0.21, p <.0001) compared to the chemotherapeutic chlorambucil alone. The combination therapy with chlorambucil demonstrated a significant 86% reduction in the risk of disease progression, relapse or death. Full data will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago on 4th June.  

In the third arm of the trial including 192 patients, Roche compares the efficacy of the type-II-anti-CD20 antibody GA101 versus its type-I-anti-CD20 blockbuster MabThera (rituximab) both in combination with chlorambucil. According to Roche GlycArt’s head, Pablo Umaña, GA101 has been glyco-optimised to show improved antibody-dependent cellular cytotoxicity and direct cytotoxicity. Roche said that at this time, no formal comparison between the GA101 and MabThera/Rituxan arms can be made as the number of PFS events required for that formal analysis has not yet been reached. However the company has filed for market authorisation in the US and the EU based on the CLL11 study.  

CLL is one of the most common forms of blood cancer and each year it causes approximately 75,000 deaths across the globe. The CLL11 study included elderly people with previously untreated CLL who were often not able to tolerate existing aggressive treatment options. According to Roche, no new safety signals were detected for either GA101 or MabThera/Rituxan. The most common severe adverse events for GA101 were infusion-related reactions (IRRs) and low cell counts of neutrophile (neutropenia).

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-02/rituxan-successor-succeeds-in-phase-iii.html

AntibodiesDenmarkNetherlands

22.05.2015 Dutch arGEN-X and Danish LEO Pharma are pairing up to develop antibody-based treatments for the chronic inflammation that causes many skin conditions.

M&ANetherlandsGermanyEU

12.05.2015 US pharma is coming to European biotech to fill their pipeline. Pfizer is paying €77.5m for an option on Dutch AM-Pharma, while Juno Therapeutics acquired German biotech Stage Cell Therapeutics for around €72m.

Rare diseasesItalyGermanyPoland

15.05.2015 Rome-based pharmaceutical group Sigma-Tau has sold its blood cancer drug programme Oncaspar to US company Baxter, who aims to spin out its biopharma business.



SurveyGermany

06.05.2015 More revenue, more staff, more funding: in the German biotech industry, all signs are pointing towards growth.

M&AUKSweden

18.05.2015 Double deal for allergy: UK’s speciality biopharma Circassia is boosting its asthma pipeline with the acquisition of Swedish asthma specialist Aerocrine as well as fellow British Prosonix.

FinancingUK

20.05.2015 The Scottish Government has announced it will double the amount of funds for rare diseases. The New Medicines Fund that was created last year for this purpose will be increased to £80m (€112m).

M&ASwitzerland

04.05.2015 Swiss crop chemical maker Syngenta AG is in talks with US company Monsanto to discuss a possible merger, insiders say.

BiofuelsEU

30.04.2015 The European Parliament has given the go-ahead on a new law limiting the use of harmful crop-based biofuel in the transport sector. The decision marks a breakthrough in the EU’s approach to biofuels.

FinancingSwitzerlandUK

29.04.2015 Biopharma start-up CRISPR Therapeutics has raised US$64m to hurry the new CRISPR/Cas9 technology to the clinic.

Events

All Events

Partner-Events

Frankfurt am Main (DE)

ACHEMA 2015

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • EVOTEC4.06 EUR4.10%
  • VITA 345.72 EUR3.06%
  • SARTORIUS165.00 EUR2.77%

FLOP

  • CYTOS0.65 CHF-4.41%
  • WILEX4.06 EUR-4.02%
  • CO.DON2.80 EUR-3.78%

TOP

  • 4SC4.61 EUR274.8%
  • SYNGENTA422.10 CHF29.1%
  • WILEX4.06 EUR26.9%

FLOP

  • CYTOS0.65 CHF-36.3%
  • MEDIGENE9.02 EUR-31.1%
  • BIOTEST76.17 EUR-22.3%

TOP

  • WILEX4.06 EUR401.2%
  • CYTOS0.65 CHF364.3%
  • 4SC4.61 EUR319.1%

FLOP

  • MOLOGEN4.89 EUR-54.7%
  • BIOFRONTERA2.30 EUR-24.1%
  • CO.DON2.80 EUR-23.7%

No liability assumed, Date: 21.05.2015