Trastuzumab emtansine: First global approval

Drugs

Volumn 73, Issue 7, 2013, Pages 755-765

  Ballantyne, Anita ^a   Dhillon, Sohita ^b  

^a Adis R and D Insight   (New Zealand)

^b ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; LAPATINIB; PACLITAXEL; PERTUZUMAB; R 3502; RG 3502; RO 5304020; TRASTUZUMAB EMTANSINE; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BREAST CANCER; BREAST METASTASIS; CARDIOTOXICITY; CELLULITIS; DIARRHEA; DRUG APPROVAL; DRUG BINDING; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG FEVER; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; HUMAN; HYPOKALEMIA; LOADING DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; NAUSEA; OVERALL SURVIVAL; PLEURA EFFUSION; PNEUMONIA; PROGRESSION FREE SURVIVAL; PULMONARY HYPERTENSION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; STOMACH CANCER; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; DRUG APPROVAL; DRUGS, INVESTIGATIONAL; FEMALE; HUMANS; MAYTANSINE;

EID: 84878641777     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-013-0050-2     Document Type: Article

References (55)

1. World Health Organization. Breast cancer: prevention and control. 2012. http://www.who.int/cancer/detection/breastcancer/en/index1.html. Accessed 11 Mar 2013.
2. Dawood S, Broglio K, Buzdar AU, et al. Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutional-based review. J Clin Oncol. 2010;28(1):92-8.
3. Hurvitz SA, Kakkar R. The potential for trastuzumab emtansine in human epidermal growth factor receptor 2 positive metastatic breast cancer: latest evidence and ongoing studies. Ther Adv Med Oncol. 2012;4(5):235-45.
4. US FDA. FDA approves new treatment for late-stage breast cancer [media release]. 22 Feb 2013. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm340704.htm.
5. Genentech Inc. Kadcyla™ (ado-trastuzumab emtansine): US prescribing information. 2013. http://www.gene.com/download/pdf/kadcyla-prescribing.pdf. Accessed 12 Mar 2013.
6. ImmunoGen Inc. ImmunoGen Inc. announces FDA approval of Kadcyla (ado-trastuzumab emtansine; also known as T-DM1) [media release]. 22 Feb 2013. http://www.immunogen.com
7. Genentech. FDA grants Genentech's trastuzumab emtansine (T-DM1) priority review for HER2- positive metastatic breast cancer [media release]. 6 Nov 2012. http://www.gene.com.
8. ImmunoGen Inc. ImmunoGen Inc. announces trastuzumab emtansine (T-DM1) significantly improved survival in the EMILIA phase III trial [media release]. 27 Aug 2012. http://www.immunogen.com.
9. Roche. FDA approves Roche's Kadcyla (trastuzumab emtansine), the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer [media release]. 22 Feb 2013. http://www.roche.com.
10. ImmunoGen Inc. ImmunoGen Inc. reports second quarter fiscal year 2013 financial results and provides quarterly update [media release]. 25 Jan 2013. http://www.immunogen.com.
11. Chugai Pharmaceutical Co. Ltd. New drug application filed for antibody-drug conjugate trastuzumab emtansine for the treatment of HER2-positive metastatic or recurrent breast cancer [media release]. 29 Jan 2013. http://www.chugai-pharm.co.jp.
12. Hoffmann-La Roche. A study of trastuzumab emtansine (T-DM1) plus pertuzumab/pertuzumab placebo versus trastuzumab (herceptin) plus a taxane in patients with metastatic breast cancer (MARIANNE) [ClinicalTrials.gov identifier NCT01120184]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://clinicaltrials.gov/show/NCT01120184. Accessed 12 Mar 2013.
13. Ellis PA, Barrios CH, Im Y, et al. MARIANNE: A phase III, randomized study of trastuzumab-DM1 (T-DM1) with or without pertuzumab (P) compared with trastuzumab (H) plus taxane for first- line treatment of HER2-positive, progressive, or recurrent locally advanced or metastatic breast cancer (MBC) [abstract no. TPS102]. J Clin Oncol. 2011;29(15 Suppl).
14. Hoffmann-La Roche. A study of trastuzumab emtansine in comparison with treatment of physician's choice in patients with HER2-positive breast cancer who have received at least two prior regimens of HER2-directed therapy (TH3RESA) [ClinicalTrials.gov identifier NCT01419197]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://clinicaltrials.gov/ct2/show/NCT01419197?term= NCT01419197&rank=1. Accessed 12 Mar 2013.
15. Krop IE, LoRusso P, Miller KD, et al. A phase II study of trastuzumab emtansine in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer who were previously treated with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2012;30(26):3234-41.
16. Hoffmann-La Roche. A study of trastuzumab emtansine (T-DM1) sequentially with anthracycline-based chemotherapy, as adjuvant or neoadjuvant therapy for patients with early stage HER2-positive breast cancer [ClinicalTrials.gov identifier NCT01196052]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/record/NCT01196052?term= NCT01196052&rank=1. Accessed 13 Mar 2013.
17. ImmunoGen Inc. ImmunoGen Inc. announces development of trastuzumab emtansine for early stage HER2-positive breast cancer [media release]. 3 Jun 2012. http://www.immunogen.com.
18. Hoffmann-La Roche. A study of trastuzumab emtansine versus taxane in patients with advanced gastric cancer [ClinicalTrials.gov identifier NCT01641939]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://clinicaltrials.gov/ct2/show/NCT01641939?term=NCT01641939&rank=1. Accessed 13 Mar 2013.
19. ImmunoGen Inc. ImmunoGen Inc. announces Genentech's fifth TAP technology license [media release]. 9 Dec 2008. http://www.immunogen.com.
20. ImmunoGen Inc. ImmunoGen Inc. to develop commercial-scale manufacturing process for trastuzumab-DM1 for Genentech; companies also amend 2000 agreement for TAP compounds targeting HER2, potentially providing increased royalties and milestones to ImmunoGen [media release]. 4 May 2006. http://www.businesswire. com.
21. ImmunoGen Inc. ImmunoGen Inc. announces Genentech's renewal of technology access agreement [media release]. 3 May 2005. http://www.immunogen.com.
22. Roche. Roche Completes Acquisition of Genentech [media release]. 26 Mar 2009. http://www.roche.com.
23. ImmunoGen Inc. ImmunoGen Inc. reports second quarter fiscal year 2008 financial results [media release]. 1 Feb 2008. http://www.immunogen.com.
24. Junttila TT, Li G, Parsons K, et al. Trastuzumab-DM1 (T-DM1) retains all the mechanisms of action of trastuzumab and efficiently inhibits growth of lapatinib insensitive breast cancer. Breast Cancer Res Treat. 2011;128(2):347-56.
25. Junttila T, Fields C, Li G, et al. Trastuzumab-mertansine retains all the mechanisms of action of trastuzumab and is extremely effective in combination with docetaxel [abstract no. 515]. 20th-EORTC-NCI-AACR symposium on molecular targets and cancer therapeutics, Geneva, 21-24 Oct 2008.
26. Lewis Phillips GD, Li G, Dugger DL, et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 2008;68(22):9280-90.
27. Li G, Fields CT, Parsons KL. Trastuzumab-DM1: mechanisms of action and mechanisms of resistance [abstract no. 223]. 22nd EORTC-NCI-AACR symposium on molecular targets and cancer therapeutics, 16-19 Nov 2010.
28. Honig A, Diessner J, Dietl J, et al. T-DM1 and pertuzumab as new tools for HER2 specific antibody-therapy against breast cancer stem cells in HER2-positive mammary carcinoma [abstract no. P1-04-05 plus poster]. Cancer Res. 2011;71(24 Suppl 3).
29. Schwall RH, Dugger D, Erickson SL, et al. Potent preclinical efficacy of herceptin-DM1 against HER2-over-expressing breast tumors in vivo [abstract no. 652]. AACR-NCI-EORTC international conference on molecular targets and cancer therapeutics, Maimi (FL); 29 Oct-2 Nov 2001.
30. Barok M, Tanner M, Koninki K, et al. Trastuzumab-DM1 is highly effective in preclinical models of HER2-positive gastric cancer. Cancer Lett. 2011;306(2):171-9.
31. Fields C, Li G, Prior WW, et al. Enhanced in vitro and in vivo activity of trastuzumab-DM1 antibody-drug conjugate combined with GDC-0941, a small molecule inhibitor of Pl3 kinase [abstract no. 3239]. 100th annual meeting of the American Association for Cancer Research, Denver (CO), 18-22 Apr 2009.
32. Gupta M, Wang B, Carrothers T, et al. Exposure-response analysis in patients with HER2-positive (HER2+) metastatic breast cancer (MBC) to assess the effect of T-DM1 on QTc prolongation [abstract no. PII-64]. Clin Pharmacol Ther. 2011;89 Suppl 1:S58.
33. Girish S, Gupta M, Wang B, et al. Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody-drug conjugate in development for the treatment of HER2-positive cancer. Cancer Chemother Pharmacol. 2012;69(5):1229-40.
34. Gupta M, Lorusso PM, Wang B, et al. Clinical implications of pathophysiological and demographic covariates on the population pharmacokinetics of trastuzumab emtansine, a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer. J Clin Pharmacol. 2012;52(5):691-703.
35. Krop IE, Beeram M, Modi S, et al. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J Clin Oncol. 2010;28(16):2698-704.
36. Lu D, Burris HA 3rd, Wang B, et al. Drug interaction potential of trastuzumab emtansine (T-DM1) combined with pertuzumab in patients with HER2-positive metastatic breast cancer. Curr Drug Metab. 2012;13(7):911-22.
37. Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367(19):1783-91.
38. Hurvitz SA, Dirix L, Kocsis J, et al. Phase II randomized study of trastuzumab emtansine versus trastuzumab plus docetaxel in patients with human epidermal growth factor receptor 2-postive metastatic breast cancer. J Clin Oncol. 2013;31(9):1157-63.
39. Burris HA 3rd, Rugo HS, Vukelja SJ, et al. Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy. J Clin Oncol. 2011;29(4):398-405.
40. Dieras V, Harbeck N, Albain K, et al. A phase Ib/II trial of trastuzumab-DM1 (T-DM1) with pertuzumab for patients with HER2-positive, locally advanced or metastatic breast cancer: interim efficacy and safety results [abstract no. P3-14-01 plus poster]. 33rd annual San Antonio breast cancer symposium, San Antonio (TX), 8-12 Dec 2010.
41. Beeram M, Krop IE, Burris HA, et al. A phase 1 study of weekly dosing of trastuzumab emtansine (T-DM1) in patients with advanced human epidermal growth factor 2-positive breast cancer. Cancer. 2012;118(23):5733-40.
42. Aogi K, Ando M, Iwata H, et al. Phase I study of single agent trastuzumab emtansine in Japanese patients with human epidermal growth factor receptor2 (HER2)-positive metastatic breast cancer (JO22591) [abstract no. P1-12-19]. Cancer Res. 2011;71(24 Suppl 3).
43. Mahapatra K, Darbonne W, Bumbaca D, et al. T-DM1-induced thrombocytopenia results from impaired platelet production in a HER2-independent manner [abstract no. A135]. 23rd AACR-NCI-EORTC international conference on molecular targets and cancer therapeutics, San Fransisco (CA), 12-16 Nov 2011.
44. Agilent Technologies. FDA approves two Dako assays as companion diagnostics for genentech's new breast cancer medicine Kadcyla [media release]. 5 Mar 2013. http://www.agilent.com.
45. Hoffmann-La Roche. A study of trastuzumab emtansine in patients with HER2 positive breast cancer who have received prior anti-HER2 and chemotherapy-based treatment [ClinicalTrials.gov identifier NCT01702571]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://clinicaltrials.gov/ct2/show/ NCT01702571?term=NCT01702571&rank=1. Accessed 12 Mar 2013.
46. ImmunoGen Inc. ImmunoGen Inc. reports second quarter fiscal year 2012 financial results and provides quarterly update [media release]. 27 Jan 2012. http://www.immunogen.com.
47. Genentech. A study of trastuzumab-MCC-DM1 in patients with HER2-positive locally advanced or metastatic breast cancer [ClinicalTrials.gov identifier NCT01120561]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/show/NCT01120561. Accessed 13 Mar 2013.
48. Roche. Roche submits application to FDA for trastuzumab-DM1 in previously treated advanced HER2-positive breast cancer [media release]. 7 Jul 2010. http://www.roche.com.
49. Genentech. An extension study of trastusumab emtansine in patients previously treated with trastusumab emtansine [ClinicalTrials.gov identifier NCT00781612]. US National Institutes of Health, ClinicalTrials.gov. 2012. http://clinicaltrials.gov/show/NCT00781612. Accessed 13 Mar 2013.
50. Genentech. A study of trastuzumab emtansine, paclitaxel, and pertuzumab in patients with HER2-positive, locally advanced or metastatic breast cancer [ClinicalTrials.gov identifier NCT00951665]. US National Institutes of Health, ClinicalTrials.gov. 2012. http://clinicaltrials.gov/show/NCT00951665. Accessed 13 Mar 2013.
51. Krop IE, Modi S, Elias A, et al. A dose-escalation study of trastuzumab-DM1(T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive, locally advanced or metastatic breast cancer (MBC) previously treated with a trastuzumab-containing regimen [abstract no. P3-14-10]. Cancer Res. 2010;70(24 Suppl 2).
52. Hoffmann-La Roche. A study of trastuzumab emtansine (T-DM1) in combination with docetaxel, and potentially pertuzumab, in patients with advanced breast cancer [ClinicalTrials.gov identifier NCT00934856]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://clinicaltrials.gov/show/ NCT00934856. Accessed 13 Mar 2013.
53. Genentech. Trastuzumab and trastuzumab-MCC-DM1 administered intravenously and GDC-0941 administered orally to patients with HER2-positive metastatic breast cancer who have progressed on previous trastuzumab-based therapy [ClinicalTrials.gov identifier NCT00928330]. US National Institutes of Health, ClinicalTrials.gov. 2012. http://clinicaltrials.gov/ct2/show/NCT00928330?term= NCT00928330&rank=1. Accessed 13 Mar 2013.
54. Krop IE, Wolff AC, Winer EP, et al. A phase Ib study evaluating safety, tolerability, pharmacokinetics (PK), and activity of the phosphoinositide-3 kinase (PI3 K) inhibitor GDC-0941 in combination with trastuzumab-MCC-DM1 (T-DM1) in patients with advanced HER2-positive breast cancer [abstract no. P6-15-02]. Cancer Res. 2010;70(24 Suppl 2).
55. Hoffmann-La Roche. A combination study of trastuzumab emtansine and capecitabine in patients with breast cancer or gastric cancer [ClinicalTrials.gov identifier NCT01702558]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://clinicaltrials.gov/show/NCT01702558. Accessed 13 Mar 2013.