Basel, 30 May 2008. New data from a Phase II trial presented at the American Society of Clinical Oncology (ASCO) 2008 meeting show that half of the patients with advanced, HER2-positive metastatic breast cancer whose disease had progressed during a Herceptin-containing regimen benefited from a combination of Herceptin and pertuzumab.1 Pertuzumab inhibits the pairing of HER2 with other HER receptors, a key mechanism of tumour growth. A combination of Herceptin with pertuzumab may lead to a more powerful blockade of the signalling pathways of HER2-positive breast cancer
“This efficacy is the best I have observed with HER2-targeted therapy without chemotherapy, and represents significant promise for women with breast cancer in the future”, said Dr Jose Baselga (Vall d’Hebron University Hospital, Barcelona, Spain), lead investigator of the Phase II trial.
“Its potential lies in its ability to target and block the most relevant pathways for tumour growth. We are hopeful the combination of Herceptin and pertuzumab used with chemotherapy will be even more effective if used to treat women newly diagnosed with advanced cancer. This combination is being investigated in the Phase III CLEOPATRA study, which is currently recruiting patients.”
In the Phase II study, nearly one in four patients saw their tumours disappear (complete tumour response, 8 %) or shrink (partial tumour response, 16 %). A further 25% of patients saw their cancer, which had been progressing, stabilise for at least 6 months. The combination of pertuzumab and Herceptin was well tolerated in this group of patients and no patients were withdrawn from the trial with treatment-related adverse events.
These results are important as, unfortunately, metastatic breast cancer cannot be cured and so patients need improved and new treatment options. The need for improved treatment options is particularly important for women suffering from advanced aggressive HER2-positive breast cancer.
The combination of Herceptin plus pertuzumab combined with chemotherapy is being evaluated in first-line metastatic breast cancer patients in another study, CLEOPATRA (CLinical Evaluation Of Pertuzumab and TRAstuzumab). This Phase III study began recruiting patients in January 2008 and is underway in 19 countries worldwide. If this study is successful, this combination of Herceptin plus pertuzumab and chemotherapy has the potential to become a new standard of care in HER2-positive metastatic breast cancer.
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For further information: Corinne Fruendt (at ASCO) F. Hoffmann-La Roche Ltd. Tel: +41 (0)616 870 236 Mob: +41 (0)795 937 216 corinne.fruendt@roche.com
Peter Flynn (in the UK) Axon Communications Tel: +44 (0)20 8439 9477 Mob: +44 (0)780 939 0667 pflynn@axon-com.com
References 1 Gelmon K, Fumoleau P, Verma S, Wardley A, Conte PF, Miles D, Gianni L, McNally VA, Ross GA and Baselga J. Results of a Phase II trial of trastuzumab (H) and pertuzumab (P) in patients (pts) with HER2-positive metastatic breast cancer (MBC) who had progressed during trastuzumab therapy. J Clin Oncol 26: 2008 (May 20 suppl; abstr 1026) 2 World Health Organization, http://www.who.int/cancer/detection/breastcancer/en/ 3 Objective response rate in a Phase II multicenter trial of pertuzumab (P), a HER2 dimerization inhibiting monoclonal antibody, in combination with Trastuzumab (T) in patients (Pts) with HER2 positive metastatic breast cancer (MBC) which has progressed during treatment with trastuzumab — J. Baselga. ASCO 2007 oral presentation.
