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Pitkäaikaisseurannan tulokset: Joka viides edennyttä melanoomaa sairastava potilas elossa kolme vuotta ipilimumabi-lääkityksen avulla

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Bristol-Myers Squibb julkaisi tänään pitkäaikaisseurannan tulokset metastaattista tai paikallisesti edennyttä, leikkaushoidon ulottumattomissa olevaa melanoomaa sairastavilla potilailla. Tutkimuksessa oli mukana 1800 potilasta ja hoitona käytettiin ipilimumabia eli Yervoyta.

  • Tässä analyysissä, joka yhdisti 12 tutkimusta, elossaolokäyrä tasaantuu noin kolmen vuoden kohdalla. Joitakin potilaita on seurattu jo jopa kymmenen vuotta.
  • Yervoylla hoidetuista potilaista noin 22 prosenttia oli elossa kolmen vuoden jälkeen.
  • Havainnot perustuvat erilaisiin annostuksiin ja hoito-ohjelmiin ja ovat yhteneväisiä pitkäaikaisen elossaolon suhteen käytettäessä Yervoyta metastasoituneessa (etäpesäkkeisessä) melanoomassa.
  • Tulokset julkistettiin kansainvälisen ESMO-syöpäkongressin lehdistötilaisuudessa Amsterdamissa 28.9.2013.

”Tässä analyysissä 26% ensilinjan potilaista  ja 20% aikaisempaa hoitoa saaneista potilaista oli elossa kolme vuotta ipilimumabihoidon aloittamisen jälkeen. Tulokset ovat rohkaisevia, varsinkin kun otetaan huomioon tulokset, joita perinteisillä hoidoilla voidaan saavuttaa.”, kommentoi tuloksia dosentti Micaela Hernberg Helsingin yliopistollisesta keskussairaalasta.

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Bristol-Myers Squibb Announces Results from Analysis of Long-Term Survival in More Than 1,800 Patients with Metastatic or Locally Advanced or Unresectable Melanoma Treated with Yervoy® (Ipilimumab)

  • In this pooled analysis of 12 studies, a plateau in the survival curve begins at approximately three years, with follow-up of up to ten years in some patients
  • Three-year estimated survival rate of 22% observed in patients treated with Yervoy
  • Findings are based on different doses and regimens and show consistency of long-term survival data for Yervoy in metastatic melanoma
  • Data presented as a late-breaker at the 2013 European Cancer Congress and highlighted at Congress press briefing

(PRINCETON, NJ, September 28, 2013) – Bristol-Myers Squibb Company (NYSE:BMY)  today announced results from a pooled analysis of survival data for 12 studies (n=1,861) in patients with metastatic or locally advanced or unresectable melanoma who were treated with Yervoy® (ipilimumab) at different doses and regimens. A plateau in the survival curve begins at approximately three years, with follow-up of up to ten years in some patients. Approximately 22% of patients were alive at three years. The data were presented today at the 2013 European Cancer Congress and were highlighted at a press briefing (Abstract # 24LBA).

Safety data were not included in this analysis. However, safety data from these individual studies have been reported. Overall, the types of adverse events (AEs) attributed to Yervoy are generally mechanism (immune)-based. Yervoy can result in severe and fatal immune-related adverse reactions due to T-cell activation and proliferation. In these clinical trials, adverse events associated with Yervoy were managed with protocol-specific guidelines, including the administration of systemic corticosteroids, dose interruption/discontinuation and/or other immunosuppressants.

 “This pooled analysis reinforces the long-term survival data seen in the individual studies and provides additional insight into the overall survival of metastatic melanoma patients treated with Yervoy,” said Brian Daniels, senior vice president, Global Development and Medical Affairs. “The durability and consistency of long-term survival observed in this analysis is encouraging as we advance the research and development of our immuno-oncology portfolio.”

“In this analysis, approximately 26% of treatment-naïve and 20% of previously treated patients were alive at three years after being treated with a Yervoy regimen,” said F. Stephen Hodi, M.D., Department of Medicine, Harvard Medical School, Dana-Farber Cancer Institute. “This pooled analysis is encouraging, particularly when considering that metastatic melanoma is one of the most aggressive forms of cancer and historically, average survival was just 6 to 9 months.”

About The Analysis

This pooled analysis was conducted to provide a more precise estimate of the long-term survival effect of Yervoy in patients with metastatic melanoma. It is comprised of patient-level data from 12 prospective and retrospective studies, including two Phase 3 trials (n=790), eight Phase 2 trials (n=821), and two retrospective, observational studies (n=250), which have been or will be reported on as individual studies.  Three studies included OS follow-up in some patients for up to ten years.

The analysis included both previously-treated (n=1,257) and previously untreated patients (n=604) who received Yervoy at different doses and regimens. The majority of patients received Yervoy 3 mg/kg (n=965) or at 10 mg/kg (n=706).  Yervoy was given every 3 weeks for 4 doses, and most studies included the option to receive either Yervoy retreatment or Yervoy maintenance therapy for eligible patients.

Median OS for the entire population was 11.4 months (95% CI: 10.7–12.1).

About Yervoy

Yervoy, which is a recombinant, human monoclonal antibody, blocks the cytotoxic T- lymphocyte antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of Yervoy’s effect in patients with melanoma is indirect through T-cell mediated anti-tumor immune responses. On March 25, 2011, the FDA approved ipilimumab 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. In July 2011, the EU approved ipilimumab 3 mg/kg for the treatment of adult patients with previously-treated unresectable or metastatic melanoma. Subsequently, on September 19, 2013, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), issued the positive opinion recommending an extension of the existing indication for YERVOY® (ipilimumab) to include treatment-naive adult patients with advanced (unresectable or metastatic) melanoma . The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. Bristol-Myers Squibb expects the European Commission to issue its decision regarding the newly proposed indication of ipilimumab in the European Union in the coming months.  Yervoy is now approved in more than 40 countries.

For full Prescribing Information, please refer to the SMPC.2

YERVOY is a registered trademark of Bristol-Myers Squibb Company.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products.  Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the investigational uses of Yervoy described in this release will lead to additional approved indications.  Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2012, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

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Contacts:

Media: Elzbieta Zawislak, +48 608 55 55 89 elzbieta.zawislak@bms.com

Melanie Brunner, 609-252-6338, melanie.brunner@bms.com; Sarah Koenig, 609-252-4145, sarah.koenig@bms.com

Investors: Ranya Dajani, 609-252-5330, ranya.dajani@bms.com; Ryan Asay, 609-252-5020, ryan.asay@bms.com

Reference

1.       European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) – Summary of Opinion. 19 September 2013. Available at: www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/002213/WC500150085.pdf Last accessed September 2013.

2.       Yervoy Summary of Product Characteristics. July 2011. Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002213/human_med_001465.jsp&mid=WC0b01ac058001d124 Last accessed September 2013.

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