Teresa Hammer was 48 years old, recently re-married and “the happiest I had ever been” when she was diagnosed with triple-negative breast cancer almost three years ago. Despite her devastating diagnosis, she has tried to remain positive. She is now in remission and continues to work, as well as babysit her 8 month old grandson, Jed.

She dreams of travelling “and more grandchildren!” She says now: “My grandson Jed has given me so much life and unconditional love. He has helped me heal.”

“I was 48 when I was diagnosed, through a general mammogram. My diagnosis came at a time when I was the happiest I had ever been. I was newly married again, with a wonderful husband. I also have two beautiful sons.

When I was told I had breast cancer, I was absolutely petrified and I felt very isolated. I remember it like it was yesterday. I thought, ‘How am I going to tell my family, my children?’ I knew it would just break their hearts and that was so hard for me to accept.

When they said it was triple-negative, I thought maybe it was not that bad. But then you learn more as you go along the journey. It was not in my lymph nodes, so that was a plus.

I worked all the way through my treatment, as many hours as I could. My job is in administration and I do a lot of commercial quotes for the flooring industry, so it is a customer service role. Having ‘chemo brain’ was so hard to cope with on most days. But my work colleges supported me, and made me feel most welcome at work.

I do believe that still being able to work kept me strong.

The treatment was really hard. I had beautiful long hair and I lost it, along with my fingernails, my toenails, my eyelashes – I lost every hair on my body. My teeth fell apart, so I had to have them fixed. My hair has grown back, but it is not the same hair. There is no curl. It is still very ‘chemo burned’ at the back and it came back quite grey.

My feet still get very tender. While going through the chemo my feet felt like I was walking on broken glass. When I finished the treatment, I thought that it had nearly killed me, so it must have done something!

I try to keep active and walk, to try and keep my body healthy. I have found that swimming has been my saviour to help with the soreness I still experience as a result of the treatment.

Having had triple-negative, you are always told there is a fair chance it will come back. So every night when I go to sleep I say a mantra. I say,

‘Cancer thank you for the visit, but you were never mine to keep.

Thank you for the beautiful people I have met, thank you for the treatment I have had and thank you for the lessons I have learned.

But you must never return in my body’.

It’s really important to share your stories because they can give hope to other people. When I was first diagnosed, I felt I was so different, because we were told triple-negative was less common.

But then I had a neighbour who told me his wife had been through triple-negative 20 years ago. When I heard she had survived, that gave me a lot of hope.

I would say to someone diagnosed today to cherish all of the good things.

My sister took six months off work to help support my husband and I. I will never forget what she has done; she is my world. She cooked dinner or cleaned the house so I did not have to worry about it.

My family helped out in the garden and took me to appointments when they could. I had great support from friends, my beautiful friends, and my hairdresser. My beautiful girlfriends would turn up with lasagnes or soups and just leave them on my doorstep.

Those things are the things you cherish. It gives you good energy to get you through.

Cancer has changed me. I was always a person that worried about things and stressed about things. Now I don’t. I have too much to live for, I have a beautiful husband, a beautiful family and a beautiful grandson. Jed is now eight months old and he is amazing. He is my reason for living. I have everything I need in my life to keep me strong.

I believe I am cured. But with cancer there is always that doubt.”

– Teresa shared her story in April 2017.

Singapore and Melbourne, Australia, 4 April, 2017: Independent pharmaceutical company Specialised Therapeutics Asia (ST Asia) will today relaunch a product used to relieve the pain of oral mucositis, a condition that can affect cancer patients undergoing chemotherapy and/or radiotherapy.

GELCLAIR is a bio-adherent oral gel that works by creating a protective film in the mouth, providing durable relief for the painful mouth ulcers that characterise the condition, as well as improving a patient’s ability to eat, drink, swallow and speak.^1-3

ST Asia will market and distribute the product under license from partner, Helsinn Healthcare SASwitzerland.

Chief Executive Officer Mr Carlo Montagner said GELCLAIR was a welcome inclusion to the company’s expanding oncology and supportive care portfolio.

“This product has been available in Australia before, but has been in hiatus since 2015,” he said.

“We know there is continued demand for this important supportive care product and we are delighted to make GELCLAIR available once more to patients suffering from oral mucositis in Australia.”

Internationally regarded oral mucositis expert Professor Dorothy Keefe said the condition could be extremely debilitating, even leading to malnutrition in some cases, with 20 to 40% of patients receiving conventional chemotherapy affected, as well as up to 100% of patients receiving radiation therapy for head and neck cancer.⁴

“Pain in your mouth, or ulceration in your mouth, makes it hard to eat and to swallow,” Professor Keefe said.

“Both of these factors have an impact on quality of life and people can lose 5-10% of their body weight if they are badly affected. GELCLAIR provides a protective barrier that reduces the pain experienced by patients, which is an important part of oral mucositis management.”

Australian journalist and broadcaster Julie McCrossin suffered the debilitating effects of oral mucositis while undergoing treatment for oropharangeal cancer. She described the damage inside her mouth as “catastrophic”.

“I would highly recommend GELCLAIR as a soothing, nurturing mouth treatment that helped me both physically and psychologically in my recovery, when I was suffering the pain and discomfort of treatment for throat cancer,” she said.

“With GELCLAIR, I actually felt it was helping me to start the road to recovery because I felt better. When you are going through weeks and weeks of trauma to your soft tissue, that is worth a million bucks.”

GELCLAIR is available without prescription. Ordering information is available at  www.STAbiopharma.com/gelclair. GELCLAIR can be purchased online only at http://www.chemistwarehouse.com.au or http://www.epharmacy.com.au

About Specialised Therapeutics Asia

Specialised Therapeutics Asia Pte Ltd (ST Asia) is an international biopharmaceutical company established to provide pioneering healthcare solutions to patients throughout South East Asia, as well as in Australia and New Zealand. The company is a close affiliate of Specialised Therapeutics Australia (STA), which also collaborates with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life changing healthcare solutions to patients affected by a range of diseases. ST Asia is committed to making new and novel therapies available to patients around the world, with a broad therapeutic portfolio spanning oncology, hematology, neurology, urology and ophthalmology. Additional information can be found at www.STAbiopharma.com

About Gelclair

Gelclair^® is a viscous oral gel for the management and relief of pain associated with oral lesions, particularly oral mucositis/stomatitis, which may be caused by chemotherapy or radiation therapy and irritation from oral surgery.¹ Gelclair^® forms a protective coating over the oral mucosa which shields exposed or sensitised nerve endings from over-stimulation and provides oral pain relief.^1-3 It does not irritate or sting and is non-numbing.¹

About the Helsinn Group

Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a broad development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Ireland and the US, a representative office in China as well as a product presence in about 90 countries globally. For more information, please visit www.helsinn.com.

References:

1. Gelclair^® Pack Insert. Prepared March 2016
2. Vokurka S et al. The effect of polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair) on oral microbial colonization and pain control compared with other rinsing solutions in patients with oral mucositis after allogeneic stem cells transplantation. Med Sci Monit 2011; 17(10): CR572-CR576
3. Lindsay G et al. The clinical effectiveness of Gelclair in the management of oral mucositis. Aust Nurs J. 2009; 16(9): 30-33
4. Lalla RV et al. MASCC?ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. Cancer 2014; 120(10): 1453-1461

Media Inquiries:

ST Asia Communications Manager Emma Power +61 419 149 525

TELL US ABOUT YOU AND WHEN YOU WERE DIAGNOSED.

I am 45 years old, I have two girls and I am a single mother. I was diagnosed with triple-negative breast cancer at the end of 2014. It was right on Christmas – the worst Christmas ever. My 12 year-old was just bawling her eyes out, because she equated cancer with dying.

In 2015 I had six months of chemotherapy followed by 28 days of consecutive radiation treatment. During that first chemotherapy session I bawled my eyes out for six hours straight. My sister was also diagnosed with triple-negative breast cancer last year, so now there is a big question as to why two sisters who don’t carry the BRCA gene have both got triple-negative breast cancer.

HOW DID THE DIAGNOSIS CHANGE YOUR LIFE?

I had never known what to do with my life. I always just breezed along and while I was never unemployed, I didn’t really know what I wanted to do. Now, I am actually studying radiation therapy.I am in my second year of a four-year course and I am loving it. I have found what I want to do.

DID YOU KNOW ANYTHING ABOUT TRIPLE-NEGATIVE BREAST CANCER BEFORE YOU WERE DIAGNOSED?

I knew nothing about it. I was like a deer in the headlights. I thought I just had to go with the flow and do as I was told. My cancer was a grade 3.

I had a lumpectomy but I did not need a mastectomy. I don’t let it consume my life, but yes, I know I am at higher risk of the cancer returning.

I have a fantastic oncologist and I just love her to death, because she is straight up and down. When I asked her what triple-negative meant, she said, ‘put it this way, if you had to choose any one, you don’t want this one.’ I just said, ‘I don’t do things by halves, do I?

WHAT HELPED YOU TO STAY POSITIVE THROUGHOUT YOUR CANCER DIAGNOSIS AND TREATMENT?

Without the help of the local community, I would not have got through it. The Hunter Breast Cancer Foundation organised lawn mowing, house cleaning and things like that.

HOW ARE YOU GOING NOW?

I am a very optimistic person and I surround myself with positive people.

I steer clear of people who dwell on things or hold grudges.

I was forced into a position where I was supporting two children as a single parent and not earning an income because I was sick. But you can make it work and that’s why I am at university now.

I try to stay fit and active, because I put on 40 kilograms as a result of the steroids I took along with the chemotherapy drugs. I used to be a size 6-8 and now I am a size 16. But I am fit and healthy, playing softball on a Saturday and dragon boating on a Sunday.

I am a very positive person and being diagnosed with breast cancer has changed my attitude to life, big time.

– Keryn shared her story in March 2017.

I recently bought a red Tesla. It’s a battery operated, engineering marvel that doesn’t require petrol, can be recharged via a rooftop solar panel, is sleek, modern and chivalrous to boot – with doors that open automatically on the owner’s approach.

While I’m an unapologetic and long standing motor car tragic, what really clinched the deal was the way this beautiful piece of machinery was sold to me.

Tesla does have showrooms in Australia, but you can’t actually buy these cars from a showroom.

When you go to a Tesla showroom, expert staff – obvious car enthusiasts like me – demonstrate and provide all manner of information about these cutting edge vehicles.

Our “sales” conversation was educational, informative and involved a pleasant exchange of information that ultimately, led to me purchasing a Tesla product online. At the showroom, I felt no sales pressure but was provided with enough information to make my own decision.

By being informed and well-educated by the representative, in a ‘non-salesy’, low pressure environment, I was free to consider the actual merits of the Tesla without the distraction of the typical car sales process. I knew the various Tesla representatives I had spoken to in the showroom were not receiving sales commissions, so the information provided was passionately, factually and legitimately delivered.

I tell this story because, as the CEO of Australia’s largest independent pharmaceutical company, I have made the decision that from February 1, 2017 our in field company representatives who call on current and potential prescribers of our therapies will no longer be incentivised by the volume of prescriptions written in their territories.

Instead, financial rewards achieved by our people will be based on other performance measures – like the extent of their product and therapeutic knowledge, their level of customer service and engagement, their commitment and dedication to ensuring the patients who would most benefit from our therapies are given the best chance of accessing them.

Why are we doing this? Because if you motivate frontline representatives with a financial carrot, then it is commonsense that those frontline staff are going to prioritise selling products instead of focusing on the specific needs of the patients the product can treat.

Like Tesla, I want doctors to know that when our field force representatives approach them about our therapies, they can engage in a legitimate and genuine exchange of information that is educational and informative.

I want them to feel comfortable in the knowledge that our representative is not being financially rewarded for ‘shifting more units’.

Conversely, I want our people to be truly engaged and to make customer and patient care paramount. I want them to engage and educate without the pressure of sealing a deal.

I want them to strive to achieve – but not sales targets. Success can be measured in other ways that are still tangible.

This approach does fly in the face of how most pharmaceutical companies in Australia and around the world typically operate.

But I am convinced this is the most transparent approach. Our customers – predominantly oncologists and haematologists – can see through a sales pitch. Most consumers can, in whichever industry you work.

This is not about taking an ‘airy fairy’ approach to sales. Quite the contrary. As an entrepreneur with a strong commercial bent, I care passionately about the business I founded, the pharmaceutical industry and the bottom line. Without profitability, there is no pharmaceutical industry, which is able to underpin breakthrough and life saving therapies and technologies.

I staunchly believe this approach will translate to desirable commercial outcomes, because success begins with a great product that fulfils a marketplace need.

Sales are achieved when customers are educated about a product’s merits and benefits. If you have the right product, then the outcome is assured.

When there is an inherent confidence in a product, there is no need to reiterate and ram home tired sales messages.

Our products are medicines that fulfil unmet medical needs. They are not ‘me-too’ products, but are carefully selected for in-licensing to our regions (Australia, New Zealand and South East Asia) because they are innovative and different. Like the battery operated Tesla car, they are not mainstream, but niche-market. The right people will prescribe them if they have the right information and there is a genuine medical need in the community.

Interestingly, my sales tactic sentiments are being echoed in other industries.

In recent weeks, consumer groups have called on the banking industry to come clean on how staff bonuses really work.

These groups warned that some consumers felt bullied into buying bank products by over-zealous sales people who were chasing their own bonuses, instead of providing real, transparent and legitimate information that might actually improve a customer’s financial prospects instead of their own.

The customer should always come first and in the pharmaceutical industry, I would say it is even more important.

Our customers are doctors and ultimately, the patients they care for. Their health is their most prized possession. Our sales should only be made when it’s right for them, based on the best information available, imparted by an expert, educated field force.

When the basics are in place, the rest will follow. Just ask Tesla.

*This opinion piece was published in the Herald Sun on February 10, 2017

Melbourne, Australia, 1 February 2017: International biopharmaceutical company Specialised Therapeutics will today launch a new company business model, as part of a bold plan to improve relationships with healthcare professionals.

Under this plan, sales teams will no longer be paid bonuses based on the number of prescriptions written. Instead, in field representatives will be rewarded for demonstrated customer service excellence, as well as high level product and disease knowledge.

Chief Executive Officer Carlo Montagner said similar sales models had been introduced by some of the world’s most successful companies – including Apple and Tesla –  with the focus on relationships and quality information exchange rather than a singular sales outcome focus.

“By removing the pressure of individual territory sales targets, we believe our team members can engage in more genuine and meaningful discussions with the healthcare professionals we are regularly interacting with, who at this stage are predominantly oncologists and haematologists,” he said.

“We believe that by doing business in this way, we will actually improve commercial outcomes, because it removes the ‘elephant in the room’ which is the sales message that can make both parties feel uncomfortable. This is simply a transparent and ethical way of doing business.”

ST is believed to be among the first pharmaceutical companies in the region to break away from the traditional pharmaceutical business model, which has long rewarded representatives with bonuses tied to the number of product prescriptions in their territories.

Mr Montagner added: “This model is about putting patients and the health care professionals we interact with first. It means our staff are a valuable resource across their therapeutic areas.

“Our in field liaison teams are wholeheartedly in favour of this new business model and we look forward to engaging with the medical community in a way that is transparent, genuine and meaningful as we move into 2017.”

About Specialised Therapeutics Asia

Specialised Therapeutics is an international biopharmaceutical company established to provide pioneering healthcare to patients throughout Australia, New Zealand and South East Asia. The company collaborates with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life changing healthcare solutions to patients affected by a range of diseases. Specialised Therapeutics is committed to making new and novel therapies available to patients around the world, with a broad therapeutic portfolio spanning oncology, hematology, urology and ophthalmology. Additional information can be found at www.STAbiopharma.com

Media Enquiries

STA Communications Manager Emma Power +61 419 149 525

Meet Joel Wight – PCPA Profile

Final year advanced trainee Joel Wight had his heart set on a surgical career, but as his medical training progressed, he realised this was not a long term passion. A “fortuitous” haematology rotation placement finally provided what he was looking for – cutting edge medicine with a strong focus on people. “I absolutely loved it, I fell in love with it straight away,” he recalls. With only one exam remaining and a final clinical year before his career takes full flight, he expects to combine both public and private haematology practice, admitting both systems have inherent advantages.  He expects to eventually move to a regional centre, where his skills can be of benefit to patients in both streams and where he will strive to really make a difference. 

Tell us about your journey to a haematology career.

Since I was a kid I wanted to be a doctor and never grew out of it.

When I first started as an intern I wanted to be a surgeon and all through medical school I wanted to be a surgeon. But then surgery lost its lustre for me.

I had a second surgical rotation at the end of my intern year, which I swapped out of. As it happened the thing I swapped into was a haematology rotation. It was quite fortuitous because I really enjoyed it; I fell in love with it straight away.

What did you love about it?

I think you fall in love with a specialty because of the people who inspire you.  I had a few really good mentors who practised such good medicine and I just wanted to be like them. But there are other things that made haematology really attractive. It is very cutting edge.

For example, if you look at CML (Chronic Myeloid Leukaemia), it has gone from a death sentence to a manageable, curable disease. CML is the poster child, but there are other haematological diseases where we have made some massive inroads in the past 20 years.

I also like the variety. When you do a general clinic, if you see 15 patients you might see 15 different diseases, which is kind of exciting.

The other thing I love about haematology is the ‘completeness’ of it. If you are a medical oncologist (and I say this with no disrespect at all), then by the time a patient comes to you to you, the surgeon has chopped out the tumour, the pathologist has diagnosed the tumour and the radiologist has staged the tumour. When they come to the medical oncologist, they manage the treatment. Where as in haematology, usually you get a GP referral, and then the haematologist does the bone marrow biopsy, goes to the lab, examines the blood cells and the bone marrow and makes a diagnosis. Then you come back to the patient and you give them the diagnosis and tailor a management plan that fits for them. And then you journey with them through that treatment from start to finish. Sometimes you get to cure people and you don’t need to see them again.  The hard part is when people, particularly young people, have a really nasty diagnosis. But even in that, it’s nice to be there for them when the chips are down.

What in your view are the pros and cons of public versus private practice, and what path do you expect to follow?

I think my career will probably entail both. I think the way the medical market has gone for jobs, if you want to be in a big public hospital, you need to be in the research space with a university attachment.

I am not a particularly academic person. Being in a big research institution, even though I see the importance of it, is probably not where my skills are best used. I can see myself in a regional centre, working in both public and private systems and doing laboratory medicine as well.

The advantage of private practice is that things are much more efficient and you get that continuity with your patients. In the public system, it’s  much harder to stay across everything.

I believe in public medicine, and if you want to keep your skills up in the “heavier” parts of haematology such as bone marrow transplantation you need substantial public work. But I also believe in the efficiency of the private system.  Each system has its advantages and I would like to work in both. When it comes to preparing for private practice, support from the PCPA has been an invaluable part of my advanced trainee experience and in particular, their therapy based training programs.

What in your opinion will be the next big advances in haematology that you are likely to be part of in the next 20 years?

Things are moving really quickly and in low-grade lymphoproliferative diseases like CLL, follicular lymphoma and mantle cell lymphoma, we are making real inroads. These have been considered incurable diseases, although people can live a long time. With more modern therapies like targeted therapies and immunotherapies, I think we are starting to change our paradigms. We are starting to talk about cures for these diseases.

In combination, targeted therapies and immunotherapies will probably take the place of chemotherapy in the next 10 years.  In the future it would be really nice if someone comes to you with lymphoma or CLL, to be able to say ‘you don’t need chemotherapy’.

What I would really like to see take off is immunotherapy in the aggressive tumour space.

With AML, (Acute Myeloid Leukaemia) the fact is we haven’t made any real inroads for a long time. We have improved how well we can manage it (in terms of supportive care, prognostication, stem cell transplantation etc.), but we are still using the same two drugs we were using 40 years ago. In 2017, more people still die from AML than live from it. This will be the biggest challenge for haematology in the next 20 years.

Do you have a patient who has left a lasting impression?

I have so many. One springs to mind. Mr H was an Iraqi refugee. There are very few Christians in Iraq. During the time of the first Iraq war, he was quite heavily persecuted. At some point in the war, he ended up with a brain injury at the back of his brain that controls vision. He could think normally and he could speak, but he could not see. Functionally, his eyes were fine but his brain could not interpret the signal. Mr H ended up coming to Australia as a refugee. I met him when he developed lymphoma. He was on the ward and he did not speak a word of English. His family was not there most of the time. It was a huge challenge as we had literally no way of communicating with a blind man who couldn’t speak the language unless we happened to have a family member or an interpreter. Despite everything he remained cheerful, even though he had been through so much. He was so accepting of everything. All you could do was hold his hand to let him know everything was okay, but he handled it all with such grace. The resilience of some people astounds me. I believe he is still in remission.

Also, I remember a guy who was very rough, previously using intravenous drugs and heavily involved in a bikie gang. Really serious stuff. He got a very nasty form of AML. It was just amazing to see the walls come down over a series of weeks while I was on the ward. He started off saying, ‘If you don’t cure me I am going to come after you’. But day after day, by being gracious and trying to help him, the walls came down. He left hospital in remission and he was just crying. He gave me a big hug and said, “If you ever need anything you just let me know”. That’s just a couple of people who I remember out of many.

STA spoke to Joel Wight in January 2017.

Phase 2 tnAcity trial found a significantly longer Progression-Free Survival with ABRAXANE + carboplatin compared to ABRAXANE + gemcitabine or carboplatin + gemcitabine regimens

Melbourne, Australia and Singapore, 23 December 2016: An international study has found that women with metastatic triple-negative breast cancer (mTNBC) demonstrated improved progression-free survival when treated with a combination of ABRAXANE (nanoparticle albumin-bound paclitaxel) and carboplatin, compared to other chemotherapy combinations.¹

Results from the randomised phase 2 study known as tnAcity were presented at the prestigious San Antonio Breast Cancer Symposium (SABCS) earlier this month.

Researchers found that an investigational weekly combination regimen of ABRAXANE + carboplatin had significantly longer progression-free survival (PFS) (7.4 months) compared to weekly regimens of either ABRAXANE + gemcitabine (5.4 months; P=0.02, HR 0.60 (95% CI, 0.39-0.93)) or carboplatin + gemcitabine (6.0 months; P= 0.03, HR 0.61 (95% CI, 0.39-0.94)) as first-line treatment of patients with mTNBC .¹

Australian oncologist and trial investigator Dr Nicole Potasz said these results reaffirmed the belief that an ABRAXANE/carboplatin combination was an active regimen in the first-line metastatic triple-negative breast cancer setting.

“This is a very practical study. We have never really known what the best first-line regimen is for women with triple-negative breast cancer,” she said. “We can use this phase 2 data to guide us in our choices and this study supports the safety and efficacy of the ABRAXANE/carboplatin combination.”

ABRAXANE is made available to Australian and New Zealand patients by Specialised Therapeutics Australia.

Chief Executive Officer Mr Carlo Montagner said these results were “extremely encouraging” and followed a recent qualitative survey of Australian oncologists.²

This survey revealed that almost one-third of women being treated for metastatic triple negative breast cancer were prescribed a gemcitabine/carboplatin chemotherapy combination as first line therapy.

“Results from this tnAcity study now provide more information to help guide treatment decisions,” he said.

“Moving forward, we are eagerly anticipating the results of several pivotal phase 3 clinical studies that are examining ABRAXANE in combination with potent immunotherapy agents to treat women with metastatic triple negative breast cancer.  These immunotherapy agents have already been approved for use in other cancers.

“While our data indicates that ABRAXANE is already Australia’s most prescribed IV chemotherapy in metastatic breast cancer, we believe it may play an increasingly important role in future therapy regimens, particularly for women with triple-negative breast cancer which remains a very challenging form of breast cancer to treat.”

The tnAcity trial randomised 191 women with mTNBC to receive one of three weekly regimens (dosed 2 out of 3 weeks): ABRAXANE + carboplatin, ABRAXANE + gemcitabine, or carboplatin + gemcitabine as first-line treatment.³

The study also reported that those treated with the ABRAXANE + carboplatin regimen experienced a longer median treatment duration (25 weeks) than those treated with ABRAXANE + gemcitabine (18.1 weeks) or carboplatin + gemcitabine (20.1 weeks).¹

tnAcity also found an improved overall response rate in patients treated with ABRAXANE + carboplatin (72%) compared with those treated with ABRAXANE + gemcitabine (39%) or carboplatin + gemcitabine (44%).¹ Median overall survival (OS) was longer in the ABRAXANE + carboplatin arm (16.4 months) compared with ABRAXANE + gemcitabine (12.1 months; P = 0.07, HR 0.66 (95% CI, 0.42-1.04)) or carboplatin + gemcitabine (12.6 months; P = 0.18, HR 0.74 (95% CI, 0.48-1.16)), however these differences did not reach statistical significance.¹

The most common grade ≥3 treatment emergent adverse events (TEAEs) observed in the ABRAXANE + carboplatin, ABRAXANE + gemcitabine, and carboplatin + gemcitabine arms, respectively, during the study were mainly haematologic and included neutropenia (42%, 27%, 52%), anaemia (13%, 12%, 27%), thrombocytopenia (9%, 7%, 28%), leukopenia (6%, 3%, 11%), febrile neutropenia (5%, 2%, 0%), peripheral neuropathy (5%, 7%, 2%) and fatigue (3%, 15%, 3%).¹ A median of 8 treatment cycles were initiated for the ABRAXANE + carboplatin arm and 6 cycles for both the ABRAXANE + gemcitabine and carboplatin + gemcitabine arms. The percentage of patients that discontinued any study drug due to a TEAE was 45% for ABRAXANE + carboplatin and 25% for each of the other arms. The most common AEs leading to discontinuation of any study drug included thrombocytopenia, anaemia, neutropenia and drug hypersensitivity.¹

About tnAcity^1,3

tnAcity is a phase 2/3 multicentre, open-label, randomised clinical trial conducted in 139 centres in 12 countries. The study evaluated the safety and efficacy of the investigational use of a weekly treatment regimen of ABRAXANE in combination with carboplatin or gemcitabine as a first-line treatment of women with metastatic triple-negative breast cancer (mTNBC) compared to a gemcitabine + carboplatin regimen.³

The phase 2 portion of the tnAcity trial evaluated 191 patients with mTNBC who had received no prior systemic chemotherapy treatment for their mTNBC and had an ECOG performance status of 0 or 1. Patients were randomised to one of three treatment arms: ABRAXANE 125 mg/m² + carboplatin AUC 2, ABRAXANE 125 mg/m² + gemcitabine 1000 mg/m², or carboplatin AUC 2 + gemcitabine 1000 mg/m² dosed weekly on days 1 and 8 of a 21-day cycle. The median age in each treatment arm was 55 (ABRAXANE + carboplatin), 53 (ABRAXANE + gemcitabine) and 59 (carboplatin + gemcitabine) years. The primary endpoint of the phase 2 trial was investigator-assessed progression free survival. Secondary endpoints evaluated in the study included overall survival and objective response rate (ORR).³

About Specialised Therapeutics Asia

Specialised Therapeutics Asia Pte Ltd (ST Asia) is an international biopharmaceutical company established to provide pioneering healthcare solutions to patients throughout South East Asia, as well as in Australia and New Zealand. The company is a close affiliate of Specialised Therapeutics Australia (STA), which also collaborates with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life changing healthcare solutions to patients affected by a range of diseases. ST Asia is committed to making new and novel therapies available to patients around the world, with a broad therapeutic portfolio spanning oncology, hematology, urology and ophthalmology. Additional information can be found at www.stabiopharma.com

References:

1. Yardley D, et al. nab-Paclitaxel + Carboplatin or Gemcitabine vs Gemcitabine + Carboplatin as First-Line Treatment for Patients With Triple-Negative Metastatic Breast Cancer: Results From the Randomized Phase II Portion of the tnAcity Trial. Poster 874. Presented at the 2016 San Antonio Breast Cancer Symposium (SABCS), December 6-10, 2016.
2. Data on file.
3. Clinicaltrials.gov. Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) (tnAcity). Available at: https://www.clinicaltrials.gov/ct2/show/NCT01881230?term=tnacity&rank=1. Accessed November 29, 2016.