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

Stock marketsEU

29.01.2015 Denmark's Ascendis Pharma has successfully raised US$108m with its upsized NASDAQ IPO, while Irish animal health specialist Nexvet is waiting in the wings.

Contract ResearchEU

28.01.2015 EMA recommends suspending around 750 generic medicines marketed throughout the world after India’s GVK Biosciences is accused of faking bioequivalence studies. Meds considered critically important for patients will remain available.

RegulationEU

21.01.2015 The EMA is asking for comments on how to implement the transparency rules of EU Clinical Trial Regulation, pointing to the new clinical trial portal and database as the main instrument.

Stock marketsEUGermany

21.01.2015 2014 was a record year for biotech companies on the European stock market, with a total of €2.4bn raised in the year - 25% more than in the year before.

ResearchEUUK

20.01.2015 Ebola research projects are set to receive €215m in funding from the European Commission’s IMI2 Ebola+ programme. Among the project partners are vaccine developers Glaxosmithkline, Johnson&Johnson and Merck. 

Stock ExchangeUKDenmarkFrance

16.01.2015 It's time to get used to weekly IPO plans by European biotechs. UK's drug discovery firm Redx Pharma Ltd, established just five years ago, has come of age with their £80m (€105m) IPO plans.

M&ASwitzerland

14.01.2015 Pharma kingpin Roche has launched a billion-dollar transaction for a total of US$1.2bn (€1bn), taking over the majority of US cancer specialist Foundation Medicine.

PoliticsEU

14.01.2015 The European Parliament has backed the legislation allowing individual countries to restrict or prohibit the cultivation of genetically modified crops that have been authorised at EU level.

M&AIrelandUK

13.01.2015 Shire beefs up its rare disease portfolio after acquiring NPS Pharma with the aim of becoming a leading biotech in a US$5.2bn deal. Part of the deal is the US biotech's lead portfolio of gastrointestinal and hormone replacement therapies.

M&ASwitzerlandFrance

09.01.2015 The excitement surrounding CRISPR genome editing shows no sign of abating. This month, Novartis and US biotech Intellia Therapeutics became the first ever biotech-pharma collaboration to use the groundbreaking technology.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • FORMYCON13.90 EUR12.10%
  • MAGFORCE5.10 EUR7.82%
  • SANTHERA103.00 CHF5.64%

FLOP

  • CYTOS0.32 CHF-17.95%
  • CO.DON2.15 EUR-4.44%
  • MEDIGENE3.80 EUR-4.28%

TOP

  • ADDEX3.44 CHF47.6%
  • CYTOS0.32 CHF45.5%
  • FORMYCON13.90 EUR39.1%

FLOP

  • ACTELION100.70 CHF-15.1%
  • MOLOGEN5.72 EUR-13.7%
  • BIOFRONTERA2.02 EUR-12.2%

TOP

  • SANTHERA103.00 CHF2494.5%
  • BB BIOTECH248.45 EUR96.5%
  • FORMYCON13.90 EUR80.5%

FLOP

  • CYTOS0.32 CHF-90.3%
  • 4SC0.82 EUR-50.9%
  • MOLOGEN5.72 EUR-50.8%

No liability assumed, Date: 27.01.2015