Specialised Therapeutics Australia Announces Breakthrough Cancer Drug Abraxane(R) to be PBS Listed for Metastatic Pancreatic Cancer

MELBOURNE, Australia, Oct. 31, 2014 /PRNewswire/ -- Australian biopharmaceutical company Specialised Therapeutics Australia (STA) is pleased to announce ABRAXANE^® (nanoparticle albumin-bound paclitaxel) in combination with gemcitabine, will be reimbursed via the Pharmaceutical Benefits Scheme (PBS) for patients with metastatic pancreatic cancer from 1 November.

In Australia, pancreatic cancer is the 5^th most common cause of cancer mortality. Pancreatic cancer accounts for 6% of all cancer deaths, with the lowest 5-year survival of all common cancers at 5.2%.¹

ABRAXANE was approved by the Therapeutic Goods Administration (TGA) in March 2014 with the following indication:

ABRAXANE, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.²

Both the TGA approval and PBS listing were based on the pivotal randomised Phase III trial, MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), published in the New England Journal of Medicine (NEJM) in October 2013.

This study showed ABRAXANE plus gemcitabine significantly improved overall survival, progression free survival, and response rates compared to gemcitabine alone.³

Australian oncologist Associate Professor Nick Pavlakis from Sydney's North Shore Hospital described ABRAXANE as the most significant breakthrough in pancreatic cancer in 15 years.

"I believe it is the most effective therapy (for pancreatic cancer) available on the PBS," Associate Professor Pavlakis commented. "This PBS listing is a major step and it is a new platform upon which we can move forward."

STA Chief Executive Officer Mr Carlo Montagner said: "The inclusion of ABRAXANE on the PBS for patients with metastatic pancreatic cancer is a landmark achievement and provides an important new treatment option for patients with this aggressive disease.

 "Until now, ABRAXANE has been widely available and PBS reimbursed for patients with metastatic breast cancer, but not for those with metastatic pancreatic cancer, who have been shown to also gain substantial clinical benefit.

"ABRAXANE will now be reimbursed and broadly accessible for Australian patients with metastatic pancreatic cancer and offers a new standard of care for treatment of this disease."

While ABRAXANE has been available via the PBS for metastatic breast cancer since 2009, over 1,000 Australian patients with other cancers have received ABRAXANE therapy via STA's ABRAXANE Access Program (AAP). 

Since 2009, STA has provided $13.76M of ABRAXANE free of charge via the AAP to Australians who otherwise would not have been able to receive this treatment.

For further information please contact Emma Power at Monsoon Communications on 03 9620 3333 or 0419 149 525.

About MPACT³

MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), was a Celgene-sponsored, open-label, randomised, international study of 861 patients with metastatic pancreatic cancer.  Patients were randomised to receive either ABRAXANE plus gemcitabine (125 mg/m² followed by 1000 mg/m² gemcitabine for 3 weeks followed by a week of rest) or gemcitabine alone (1000 mg/m² administered weekly for 7 weeks followed by a week of rest then weekly administration for 3 weeks followed by one week of rest). 

The primary endpoint of the study was overall survival (OS). Secondary endpoints were progression-free survival and overall response rate determined by independent radiological review. Other endpoints included the safety and tolerability of this combination in patients with metastatic pancreatic cancer.

The study reported that patients treated with ABRAXANE plus gemcitabine had a statistically significant improvement in OS compared to patients receiving the current standard of care, gemcitabine monotherapy (OS; median 8.5 months vs. 6.7 months; HR 0.72, P<0.001).³ An updated analysis of OS presented at the American Society of Clinical Oncology Gastrointestinal Conference (ASCO GI) in January 2014 showed that the survival benefit was further extended in the ABRAXANE plus gemcitabine arm, with a 2.1 month median OS improvement compared to gemcitabine alone (OS; median 8.7 months vs 6.6 months; HR=0.72; p<0.0001).⁴

Australia contributed 120 patients to MPACT.  In the Australian cohort, patients in the ABRAXANE plus gemcitabine arm showed a significant median OS benefit, with a 2.7 month improvement in median OS compared to patients in the gemcitabine alone arm (OS; median 9.4 months vs 6.7 months; HR=0.59; p=0.01).⁴

MPACT is the first phase III trial in metastatic pancreatic cancer to report greater than 3-year survival rates, with 4% of patients in the ABRAXANE plus gemcitabine arm alive after three years, and 3% of patients alive at 42 months, compared to 0% in the gemcitabine alone arm at both time points.⁴

The most common grade ≥3 treatment-related adverse events in MPACT for ABRAXANE plus gemcitabine vs. gemcitabine alone were neutropenia (38% vs. 27%), fatigue (17% vs. 7%), and peripheral neuropathy (17% vs. 1%), respectively.  The median time to neuropathy improvement by one grade from grade ≥3 was 21 days in the ABRAXANE plus gemcitabine arm compared to 29 days in the gemcitabine alone arm. Neuropathy improved to grade 1 or lower in a median of 29 days for the ABRAXANE plus gemcitabine arm and was not reached for the gemcitabine alone arm.  There was no difference in serious life threatening toxicity (4% in each arm).³

About ABRAXANE

Developed using the proprietary nab^(TM) technology platform, ABRAXANE is a nanoparticle protein-bound chemotherapy agent. ABRAXANE combines paclitaxel with albumin, a naturally-occurring human protein, to deliver paclitaxel to the tumour and therefore eliminates the need for solvents in the administration process.² ABRAXANE is approved for the treatment of metastatic breast cancer, advanced non-small cell lung cancer (NSCLC) and metastatic pancreatic cancer.²  In Australia, ABRAXANE is currently listed on the PBS for the treatment of metastatic breast cancer and HER2 positive breast cancer in combination with trastuzumab, and metastatic pancreatic cancer.  ABRAXANE is not PBS listed for the indication of NSCLC.

ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: adjuvant pancreatic cancer, bladder cancer, colorectal cancer, NSCLC and expanded applications for breast cancer.

BEFORE PRESCRIBING PLEASE CONSULT THE ABRAXANE PRODUCT INFORMATION AVAILABLE AT www.specialisedtherapeutics.com.au

ABRAXANE^® Minimum Product Information

ABRAXANE: Nanoparticle albumin-bound paclitaxel 100 mg powder for injection (suspension)

Indications:

Metastatic carcinoma of the breast after failure of anthracycline therapy. 

First-line treatment of non-small cell lung cancer (NSCLC) in combination with carboplatin, in patients who are not candidates for potentially curative surgery and/or radiation. 

First-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

Contraindications: Baseline neutrophil count < 1.5 x 10⁹/L, hypersensitivity to ABRAXANE or albumin, pregnancy, lactation.

Precautions: Administer under the supervision of a physician experienced in the use of chemotherapeutic agents.  ABRAXANE is not clinically interchangeable with other paclitaxel formulations.  Dose dependent and dose limiting bone marrow suppression (frequent peripheral blood cell counts recommended for all patients). Peripheral neuropathy, sepsis, severe hypersensitivity, pneumonitis, patients with hepatic impairment, cardiotoxicity, affects fertility, pregnancy (category D), lactation, paediatric use.  In elderly - more frequent myelosuppression, peripheral neuropathy, arthralgia, diarrhoea, decreased appetite, dehydration and epistaxis.  Refer to full PI for more information.

Interactions:  Inhibitors or inducers of either CYP2C8 or CYP3A4 (e.g. inhibitors: erythromycin, ketoconazole, fluoxetine, imidazole antifungals, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir; inducers: rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine).  CYP2C8 and CYP3A4 substrates, quinidine, PEG-35 castor oil, quercetin, clozapine, morin, and resveratrol. Refer to full PI for details.

Adverse Effects: Very common effects in ABRAXANE monotherapy: Neutropenia, anaemia, leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression, peripheral neuropathy, neuropathy, hypoaesthesia, paraesthesia, myalgia, arthralgia, asthenia, nausea, vomiting, diarrhoea, constipation, stomatitis, anorexia, pyrexia, alopecia, rash, fatigue, mucositis.  Additional very common effects in combination with carboplatin:  Peripheral oedema, dyspnoea, decreased appetite.  Additional very common effects in combination with gemcitabine:  chills, abdominal pain, dysgeusia, headache, dizziness, dehydration, hypokalemia, cough, epistaxis, weight decreased, ALA increased, pain in extremity, insomnia, depression, anxiety.   This is not a full list of adverse effects – refer to full PI for more information. 

Dose:

Metastatic Breast Cancer: ABRAXANE 260 mg/m² every 3 weeks. 

NSCLC:  ABRAXANE 100 mg/m² on days 1, 8, and 15 of each 21-day cycle.  Recommended carboplatin dose is AUC = 6 mgmin/mL on day 1 only of each 21-day cycle, beginning immediately after the end of ABRAXANE administration.  

Metastatic Pancreatic Cancer:  ABRAXANE 125 mg/m² on Days 1, 8 and 15 of each 28-day cycle. Recommended gemcitabine dose is 1000 mg/m² beginning immediately after the end of ABRAXANE administration on Days 1, 8 and 15 of each 28-day cycle.

Dose adjustments: Required for severe neutropenia, severe peripheral neuropathy and certain non-haematological toxicities (see full PI for details).  Hepatic Impairment:  Patients with severe hepatic impairment should not be treated with ABRAXANE.  Consider dose reduction in patients with bilirubin >2 ULN.  Refer to full PI for details.

Administration: Administered intravenously over 30 minutes.  No premedication to prevent hypersensitivity reactions is required for ABRAXANE.  Do not mix any other drugs with the ABRAXANE infusion.

Preparation for Intravenous Administration: Reconstitute with 20 mL of 0.9% Sodium Chloride.  Inject appropriate amount of reconstituted ABRAXANE into an empty, sterile, polyvinyl chloride (PVC) or non-PVC type IV bag for IV infusion.  Protect from light.  For more details, refer to full PI.

Patients should consult their oncologist or the ABRAXANE Consumer Medicine Information available on www.specialisedtherapeutics.com.au

ABRAXANE^® is a registered trademark of Celgene Corporation.

ABRAXANE^® is distributed by STA under license from Celgene Corporation, in Australia and New Zealand.

About Specialised Therapeutics Australia, Pty Ltd

Specialised Therapeutics Australia (STA) is dedicated to working with leading biotechnology and pharmaceutical companies worldwide. Our primary objective is to enable unrestricted access to breakthrough acute care therapies and genomic diagnostics to people with high unmet medical needs living in Australia and New Zealand.

The STA therapeutic portfolio and pipeline at present encompasses oncology, haematology, gene expression assays, ophthalmology and infectious diseases. STA also has interests in the therapeutic areas of respiratory, dermatology, endocrinology and central nervous system (CNS). Additional information can be found at http://www.specialisedtherapeutics.com.au

References:

1. Cancer in Australia. An Overview 2012. Australian Institute of Health and Welfare (AIHW).
2. ABRAXANE Product Information
3. Von Hoff DD et al. Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine. N Engl J Med 2013; 369(18):1691-703.
4. Goldstein D et al. Oral Abstract # 178. Updated survival from a randomized phase III trial (MPACT) of nab-Paclitaxel plus gemcitabine versus gemcitabine alone for patients (pts) with metastatic adenocarcinoma of the pancreas. ASCO GI 2014.

Monsoon Communications
Level 1 350 Collins Street
Melbourne VIC 3000
Ph: 03 9620 3333
www.monsoon.com.au

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