News

Major success for T-DM1
Enlarge image

Clinical TrialsSwitzerlandAustria

Major success for T-DM1

02.10.2012 - Roche's trastuzumab emtansine (T-DM1) appears to keep its promises. The armed antibody significantly extended overall survival in breast cancer patients.

Roche presented the latest big pack of Phase III data for T-DM1 at the ESMO conference currently being held in Vienna. The EMILIA study has shown that people with previously treated HER2-positive metastatic breast cancer survived significantly longer when treated with T-DM1 compared to those who received the standard-of-care, a combination of lapatinib and capecitabine. Results showed the risk of death was reduced by 32% for people who received the antibody-drug conjugate compared to those who received lapatinib plus Xeloda (HR=0.68; P=0.0006). People in the study treated with trastuzumab emtansine survived a median of 5.8 months longer than those who received lapatinib and Xeloda  (median overall survival: 30.9 months vs. 25.1 months). No new safety signals were observed and adverse events (AEs) were consistent with those seen in previous studies, with fewer people who received trastuzumab emtansine experiencing Grade 3 or higher (severe) adverse events than those who received lapatinib plus Xeloda (40.8 percent vs. 57.0 percent).

Representatives from Roche and industry experts were "extremely pleased" with the results. "Roche is moving away from Herceptin, with successors that are not just an inch better, but much, much better," said Andrew Weiss from Vontobel. Simos Simeonidis from SG Cowen has laid out a bullish marketing scenario, expecting that T-DM1 could earn more than its predecessor Herceptin (US$5.4bn) last year. "And since it will probably be priced at a meaningful premium to Herceptin, we think T-DM1 could end up as one of the biggest biotech drugs", Simeonidis said.

Genentech Inc., a Roche subsidiary situated in San Francisco (USA), is the developer of T-DM1. The company has already filed a marketing application for the drug to the Food and Drug Administration (FDA) in the US. The development was accomplished under an agreement with ImmunoGen, Inc. from Waltham (USA). The company from Massachusetts provides the linker chemistry and the compound drug's cancer killing agent, which is targeted by the antibody (trastuzumab) to Her2neu tumour cell receptors. ImmunoGen calls its technology TAP, Targeted Antibody Payload. The cytotoxic agent is a derivative of maytansine that inhibits the assembly of microtubules. Maytansines are potent toxins that naturally occur in the shrubs and trees of the Genus Maytenus spp.

© eurobiotechnews.eu/pd

http://www.european-biotechnology-news.com/news/news/2012-04/major-success-for-t-dm1.html

PoliticsEU

15.09.2014 Jean Claude Juncker, the European Commission President-elect revealed his new Commissioners last week, whilst announcing a change in the units dealing with medicines, medical devices and health technology.

BiosimilarsGermanyFrance

12.09.2014 The 2011 collaboration of Boehringer Ingelheim and Eli Lilly is bearing fruit. An insulin biosimilar developed through the partnership has now been approved in Europe - the first-ever generic version of this class.

FinancingNetherlands

11.09.2014 Cystic fibrosis specialist Proqr Therapeutics has set the terms for its upcoming IPO at US-American stock exchange NASDAQ.

Clinical TrialsUKSweden

09.09.2014 In the midst of the hustle and bustle of the European Respiratory Society’s International Congress 2014, Astrazeneca quietly announced the disappointing results of its latest benralizumab study.

BusinessDenmark

04.09.2014 After their arthritis product’s Phase IIb failure, Novo Nordisk A/S is pulling out of all research and development activities within inflammatory disorders.

BusinessBelgiumIrelandSwitzerland

02.09.2014 In the face of declining revenue, Belgian biopharmaceutical company Thrombogenics has decided to spin out its cancer research and development activities.

ResearchUKSwitzerlandItaly

29.08.2014 Just a week ago, Glaxosmithkline defused the WHO’s claim that an Ebola vaccine could be ready by 2015. Now, the British company’s own candidate vaccine is to be rushed to human trials with the help of funding from an international consortium.

BusinessGermany

24.08.2014 Germany's Morphosys is licensing a preclinical bi-specific antibody for the treatment of prostate cancer from Emergent Biosolutions. The US developer will rake in up to €138m for the commercialisation rights to the compound.

BusinessUK

20.08.2014 Biopharmaceutical contract manufacturer Fujifilm Diosynth Biotechnologies is expanding its cell culture manufacturing capacity further with a new 2,000l single-use bioreactor at the company’s site in Billingham, UK.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • ADDEX3.13 CHF4.68%
  • CO.DON3.15 EUR4.30%
  • BB BIOTECH146.25 EUR2.17%

FLOP

  • WILEX2.35 EUR-5.24%
  • SANTHERA89.15 CHF-3.10%
  • EVOTEC2.93 EUR-2.33%

TOP

  • SANTHERA89.15 CHF31.2%
  • CO.DON3.15 EUR26.0%
  • PAION3.01 EUR24.4%

FLOP

  • ADDEX3.13 CHF-22.3%
  • EVOTEC2.93 EUR-21.2%
  • MEDIGENE3.95 EUR-15.1%

TOP

  • SANTHERA89.15 CHF2117.7%
  • CO.DON3.15 EUR250.0%
  • PAION3.01 EUR189.4%

FLOP

  • CYTOS0.24 CHF-94.0%
  • MERCK KGAA67.67 EUR-40.6%
  • THERAMETRICS0.09 CHF-40.0%

No liability assumed, Date: 17.09.2014