Is Zytiga Legislation Encouraging Docetaxel Treatment ?

Zytiga is currently approved for use in the post chemotherapy setting and the label stipulation is that patients must have received at least one course of docetaxel based chemotherapy. Use of Zytiga pre chemotherapy is considered an off-label use of this drug and the drug is currently not approved in this setting. Insurance company reimbursement of drug costs will only be made for use of the drug according to the label, and that means post chemotherapy. Furthermore the approved prescription usage of Zytiga in some countries requires prior docetaxel treatment.

This raises the possibility that physicians will administer docetaxel so that the patient qualifies for Zytiga treatment. Low dose docetaxel has already been used in this context and perhaps the restrictive legislation on Zytiga usage is actually encouraging the use of docetaxel chemotherapy to qualify for the post chemotherapy criterion.

Approval of Zytiga by the FDA for use pre chemotherapy will resolve this ridiculous situation by allowing the drug to be used on label at an earlier stage without the need for chemotherapy. In the pre chemotherapy setting Zytiga has been shown to delay the need for chemotherapy by over 2 years. The current situation encourages the use of chemotherapy whereas Zytiga was designed to replace the need for chemotherapy.

Zytiga Approved for use in Australia

A drug which extends the life of men with advanced prostate cancer has been approved for use in Australia.
The drug Abiraterone Acetate (Zytiga) is the first of a new generation of drugs to be approved by the Therapeutic Goods Administration (TGA) for men who have become resistant to prostate cancer hormone treatments. This drug was approved in April 2011 in the USA and May 2011 in Europe, but has taken over an extra year before it has finally been approved in Australia.

Professor of medical oncology at the University of Western Sydney Paul De Souza said for the past five years chemotherapy had been the only option for many men with this type of advanced prostate cancer, apart from those in clinical trials.
He said there had been intense drug trials for the past three to four years testing the new treatments.
"This drug, Zytiga, is the first cab off the rank," Prof De Souza told AAP.
"It’s a pill, it’s extremely well tolerated and it prolongs survival.
"it works and it doesn’t cause the side effects that chemotherapy does."
He said two separate trials had shown the drug prolongs survival in men who have failed hormone treatment and chemotherapy but it also worked in men before starting chemotherapy.
Prostate Cancer Foundation of Australia chief executive Dr Anthony Lowe said the drug’s potential to extend the life of sufferers was a significant breakthrough.
"This is a group of men for whom, until 12 months ago, there was really nothing available to them. This is a very important development," he told AAP.
Zytiga works by targeting prostate cancer cell growth by stopping male hormone production at all sources – the testes, adrenal glands and the tumour itself.
University of Queensland Associate Professor of Medicine Dr Paul Mainwaring said prostate cancer growth was fuelled by androgens naturally produced in men.
"By inhibiting androgen production at all sources this new therapy removes the fuel from the fire, reducing the cancer’s ability to grow or spread," Dr Mainwaring said.

The drug’s manufacturer Janssen is working with the federal government to add the therapy to the Pharmaceutical Benefits Scheme (PBS) to be subsidised in Australia.

NICE Confirms Approval of Abiraterone for use on the NHS

NICE the natinonal institute for clinical excellence which is the UK's government drug rationing body has issued its final draft guidance recommending Abiraterone (Zytiga) for use on the natinonal health service NHS of England and Wales to treat advanced prostate cancer.

o        Abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen

NICE Technology appraisals, TA259 - Issued: June 26 2012

NICE recommends abiraterone as a possible treatment for some adults with metastatic prostate cancer who have already had treatment to reduce testosterone and have had docetaxel chemotherapy (see below).

Who can have abiraterone?

You should be able to have abiraterone if you’ve had docetaxel chemotherapy but your disease has stopped responding to treatment.

Why has NICE said this?

NICE looks at how well treatments work, and also at how well they work in relation to how much they cost the NHS. NICE applies special considerations to treatments that can extend the lives of people who are nearing the end of their life. NICE recommended abiraterone because it works better than other treatments available on the NHS. Although it also costs more than other treatments, this was justified by the benefits it provided when the special considerations were applied.

Zytiga Still Working After 6 Years

A drug pioneered by scientists in the UK allows prostate cancer patients to live longer and enjoy a better quality of life.

The oral drug, abiraterone, was designed by Professor Gerry Potter at the Institute of Cancer Research and has been developed through clinical trials by Professor Johann de Bono at the Royal Marsden Hospital in London.

It has been proven to drastically decrease pain and improve the personal well-being of prostate cancer patients.

“Prostate cancer is a pretty horrible cancer, a dehumanising disease, and this pill improves the quality of life and survival rate,” said Prof. de Bono, an honorary consultant in medical oncology at The Royal Marsden Hospital.

The drug gives hope to prostate cancer patients at the late stages of the disease when chemotherapy, surgery or other drugs would have failed. It decreases the incidence of death by about a third but, according to Prof. de Bono, it is “not just about extending survival but also about improving the quality of life”.

Officially, abiraterone can extend survival by about five months but some men live considerably longer.

“Averages are hard to quantify,” he said. “I have a patient who had been living on morphine because of the pain but when he started taking abiraterone he came off the morphine and, six and a half years later, he’s still alive and not in pain,” Prof. de Bono said.

Soon, patients will be able to take the drug even prior to chemotherapy. “Our goal is to make chemotherapy a thing of the past,” he said.

It is deemed the most common cancer in men worldwide and the second most common killer among men after lung cancer.

Patients on abiraterone – which only has minimal side effects – would need to take four pills a day.

Abiraterone is also being tested on patients with advanced breast cancer. The indications are that even children with rare inherited diseases will eventually benefit from the drug.

So is this a miracle cure?

“Please don’t hype it up. We all have to die one day,” said Prof. De Bono. “It doesn’t cure but it does improve the quality of life.”

His “primary goal” in life is to accelerate the process of drugs to move from experimental stage to treatment, which, at the moment, takes approximately 10 years.

“This is a time of great change for cancer medicine because genomic technology allows us to decipher exactly what’s driving each cancer,” he said, explaining that precision medicine allowed researchers to develop specific drugs to target the area that is being hijacked by cancer.

“It’s a question of giving the right patient the right treatment at the right time,” he said.

Because these drugs are expensive, the key challenge is funding and the medical world is trying to minimise cost failures and accelerate success. “How are we, as a society, going to afford such drugs, particularly in these stringent times?”

Prof. de Bono describes cancer as a “complicated beast” but his goal is to eventually “find a drug which cures”.

He spends half his time in the lab and half with patients, which takes its toll on him: “I am ageing very rapidly,” he joked but it is clear that he is driven by passion for his job.

He recounted that only the other day he had received an e-mail from a woman in Australia, whom he had never met. She wanted to thank him because her father had been bedridden with prostate cancer but was now even swimming.

“These true stories keep you going,” he said.

Doctors to Increase Use of Zytiga

A market research company, today released the results of its ASCO Impact Report, a survey of physicians attending the 2012 annual meeting of the American Society of Clinical Oncologists (ASCO). The survey was designed to evaluate the relevancy and effectiveness of company-sponsored clinical data and promotions at ASCO.
Encuity's survey results revealed that this year's event had a significant impact on the treatment plans of oncologists and hematologists in attendance—with 76% indicating that they are likely to change their patient treatment plans based on ASCO findings.
New breast cancer and prostate cancer treatment plans gained the most traction. Among the ASCO-attending physicians surveyed, 45% intend to change their breast cancer treatment plan once Genentech's T-DM1 becomes available, while 44% intend to increase their use of Johnson & Johnson's prostate cancer treatment, Zytiga®.
The majority, 86%, of ASCO-attending physicians also awarded the highest overall "presentation of information" rankings to T-DM1. This endorsement was closely followed by Zytiga®, earning "very or extremely valuable" ratings from 73% of physicians surveyed.
"It is clear that several companies delivered clinical presentation home runs at ASCO, while others did not," said Michael Turner, General Manager of Encuity Research.  "The study also showed that ASCO will have a significant impact on the future behavior of physicians in attendance.
The ASCO Impact Report provides an encompassing view of ASCO attendees' intent to change treatment plans, their perception of clinical information presented, and their ratings of information offered by pharmaceutical and biotech companies.
This report is based on an online survey of 100 oncologists and hematologists who attended the event.

Zytiga Approved in Singapore

Zytiga has been approved by the Health Sciences Authority of Singapore for use in treating advanced prostate cancer.

SINGAPORE: A new drug to treat advanced stage prostate cancer may prolong lives and mitigate pain for patients whose conditions have worsened while on, or after chemotherapy.

Called Zytiga, the pill has been approved by the Health Sciences Authority of Singapore.

Prostate cancer is the third most common cancer among Singaporean men.

In global clinical trials, patients lived an average of 4.6 months longer after taking the drug.

The pill suppresses the body's production of testosterone, the male sex hormone, which has been linked to the growth of prostate cancer.

Drug manufacturer Janssen said it is priced competitively with other comparable treatments in the market.

The National Cancer Centre Singapore said local patients have taken well to the drug.

Doctors said side effects such as fluid retention and low potassium levels are manageable when taken with prednisone.

 

Zytiga Still Working After 3 Years

Michael Wells, 65, a retired construction worker from Oakville in California's Napa Valley, was diagnosed nearly 12 years ago with prostate cancer that had spread to his bones. Standard hormone and radiation treatments kept it in check for many years, but when it started growing, he enrolled in the clinical trial study of Zytiga.

Zytiga gave him high blood pressure but other than that, "I have not noticed any difference taking the pills -- I've always had hot flashes" on prostate medicines, he said.

He has now been on Zytiga for three years now, and scans show his cancer is in check.

"It's worked for me, and it's still working," Wells said.

Terminal Patient Now Enjoying Life Thanks to Zytiga

A man with terminal prostate cancer is urging officials to fund a £32,000 a year drug that is keeping him alive.

Dave Lee has been battling the cancer since 2004 but says the drug, Abiraterone, is his final hope.

He says the drug, which has been paid for with a temporary Government fund, has made a huge difference to his life since he began taking it four months ago.

He now has far more energy and suffers less from pain and tiredness – and is able to spend much more time enjoying life with his wife Jacky.

He has also been able to raise £12,500 for charity in recent months and has set up what they believe is the only support group in the region to help others with his condition.

But the 61-year-old is now waiting for officials at the Government's National Institute for Health and Clinical Excellence (NICE) to decide whether they will allow the drug to be routinely available on the NHS.

NICE officials have recommended that the drug should be approved – but a final decision, expected later this month, has yet to be made.

Mr Lee, from New Row in Messingham, said: "It's really important. There are people taking this drug like me who are enjoying a longer life and more quality of life for a while longer.

"I know it's an expensive drug, but while the drug is available, it ought to be used."

Abiraterone is a treatment for prostate cancer that aims to block the production of certain male hormones that stimulate prostate cancers to grow.

And without the drug, Mr Lee said there would be no more treatments available to help him fight the cancer.

"It could have been the end for me, looking back a few months," he said.

"Now I can enjoy a reasonable quality of life and travel and see a bit of the world."

Mr Lee was told in 2004 that he might only have five years to live, but he has confounded the doctors ever since. The new drug extends life by around four months in people with advanced prostate cancer.

But he says with new treatments like Abiraterone coming on the market all the time, medicine offers hope that his life could continue for much longer than that.

Mrs Lee said: "The drug has made a big a difference. He has a lot more energy and he is feeling a lot better.

"We have always taken the view that we want to make each day count and make the most of every day."

And she said it was vital the drug was approved for use.

Zytiga Submitted For FDA Approval Pre Chemotherapy

Janssen Submits Additional Marketing Applications for ZYTIGA® in the European Union and in the U.S.



Simultaneous Submissions Based on Data from Pre-chemo Prostate Cancer Study

Janssen-Cilag International NV announced today it has submitted a type II variation to the European Medicines Agency (EMA) for ZYTIGA^®; simultaneously, Janssen Research & Development, LLC submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA);  Both applications are intended to extend the use of ZYTIGA administered with prednisone for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and before chemotherapy.  
Both regulatory applications follow the announcement of results observed from pre-specified interim analyses of the international Phase 3, randomized, double-blind, placebo-controlled COU-AA-302 clinical study.  This study, which included 1,088 asymptomatic or mildly symptomatic men with mCRPC who had not received chemotherapy, evaluated the effect of ZYTIGA plus prednisone on the co-primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) compared to placebo plus prednisone. Data from this study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) earlier this month.
"We're delighted to move forward so quickly with these regulatory submissions, building on the momentum created by the data presentation two weeks ago," said Michael L. Meyers, M.D., Ph.D., Vice President, Compound Development Team Leader, ZYTIGA.  "We look forward to working with the FDA and EMA to make ZYTIGA available for men with metastatic prostate cancer earlier in the course of their disease."
The company previously announced the study was unblinded based on the unanimous recommendation of an Independent Data Monitoring Committee (IDMC).  Based on these results, the IDMC also recommended that patients in the control arm be offered treatment with ZYTIGA.
"As a company, we strive to develop innovative therapeutic options that meet the unmet needs of patients suffering from devastating diseases such as mCRPC," said William N. Hait, M.D., Ph.D., Global Head, Janssen Research & Development and Head, Oncology Therapeutic Area.  "These regulatory submissions for ZYTIGA are a clear example of our efforts to bring extraordinary oncologic therapies to those with the greatest need."

Patients Report Zytiga Best Medication for Prostate Cancer

A survey of prostate cancer patients conducted by Treato shows that Zytiga is the favoured medication with more positive responses than any other treatment. The survey also reveals that the chemotherapy agents Taxotere and Docetaxel do not help many patients. The survey conducted on 345 prostate cancer patients reported the following details.

Survey of 345 prostate cancer patients

Zytiga

·         More patient posts reported that Zytiga helped them when used for Prostate Cancer (3354% higher than average of other Prostate Cancer treatments)

abiraterone

·         More patient posts reported that abiraterone helped them when used for Prostate Cancer (1150% higher than average of other Prostate Cancer treatments)

Flutamide

·         An average number of patient posts reported that Flutamide helped them when used for Prostate Cancer

Docetaxel

·         Fewer patient posts reported that Docetaxel helped them when used for Prostate Cancer (58% lower than average of other Prostate Cancer treatments)

Taxotere

·         Fewer patient posts reported that Taxotere helped them when used for Prostate Cancer (87% lower than average of other Prostate Cancer treatments)

Zytiga Saves Lives

Keen runner Eddy Newman has terminal prostate cancer. Here he reflects on how the new drug Zytiga gave him back his life.

In March 2006, I had aggressive prostate cancer at 59. I was very fit. I was a long distance runner and I loved every mile of it.

All the spare time I had was spent running or in the gym. I’d had a heart attack two years previously, but within six weeks, on a cold, wet December Sunday, I ran a 10k for the RNLI – it took me an hour and 25 minutes, but I made it.

I went on to live a normal life. I carried on with my training and running and completed many marathons.

A friend of mine had told me he had been diagnosed with prostate cancer and advised me to go and have a blood test. I wasn’t interested – my father had died of prostate cancer and I didn’t want to know if I had it.

My friend Graham nagged and nagged me to get a test and, eventually, I couldn’t put up with his nagging any more so I went and had the blood test. I’m now so grateful for his persistence.

When they told me I had prostate cancer it became another challenge to me – it meant nothing to me. I realised it could kill me, but we all have to die some day.

At the time in Wales, the only cancer treatment available to me was hormone injections, radiotherapy and chemotherapy. I wasn’t told what chemotherapy was or how it would be given.

My idea of chemotherapy was you went into a machine, lost all your hair and afterwards sat around all day in a white robe. From what I’d heard, I believed chemotherapy was the killer of cancer and gave you a chance of life.

I made up my mind if the cancer got out of control chemotherapy would be my ace card to save my life. How gullible I was.

I put off treatment for five weeks to allow me to run the London Marathon. But, in the back of my mind there was another reason why I didn’t want treatment – I had another marathon to run, this time it was against a horse.

But my wife had other ideas – she told me to grow up and she put her foot down. She told me in a very certain manor: “You start the treatment today,” and her word being law, I had my first hormone injection. I went on to run the marathon against the horse – 24 miles across the Welsh mountains – but the horse won.

I had hormone injections until May 2007. They affected my way of life. It would take all of my will power to run a race. I would start a race in the middle of a pack of runners suited to my pace and finish time. But after a short period of time, I’d run out of steam; I couldn’t run anymore. I had to push myself to carry on running. I would pick my pace up again and finish the race in a good time.

I had 30-plus sessions of radiotherapy from December 2006 and I was able to fit it in around my daily life.

By May 2007, my PSA had come down to 1.5 and I decided no more hormone injections. For the rest of the year my cancer was monitored every three months until September 2009.

The cancer and I had an agreement – I leave the cancer alone and it would leave me alone. It was a good arrangement.

My cancer stayed under control until September 2009. It then let me know it was in control, not me, it had better aces than I did. One morning, when I was running, I felt a pain in my right hip – it’s still there, but I’ve learned to live with it.

A month later, I was told my PSA had gone up and that I should start hormone injections again. I told the doctor all the reasons why I didn’t want them again and she said I was playing a dangerous game. She offered me tablets instead of the injections. I told her about the pain in my hip and she advised me to take the tablets and go on hormone injections – it was the only way they could control the cancer. I agreed to take the tablets. She had my best interests at heart.

In November, although my PSA had come down again, I agreed to go back on hormone injections.

But six months later, it was very high and I had a bone scan. It showed the cancer had left my prostate and had moved into my spine. I was told there’s nothing that could be done for me – the cancer will kill me. I was told it could take up to 18 months to five years.

My wife took the news very badly; she was very upset. I told her: “I’m a short time living and a long time dead. We’ve got five wonderful years – let’s go live a life.”

In November 2010, the doctors told me the cancer was starting to get out of control and I asked if I could go on chemotherapy – I was about to play my ace card. The cure for my cancer.

I struggled to cope with the chemotherapy. After hearing a radio programme about chemotherapy and cancer, I was advised to contact Keith Cass at the Red Sock Campaign, who also has advanced prostate cancer.

This person was a total stranger to me but we spoke for an hour and a half about prostrate cancer and the treatment and drugs available, including abiraterone, an experimental drug that wasn’t available on the NHS.

February 2011 was a bad month for me as I couldn’t cope with chemotherapy – I was very, very tired and depressed. I asked my doctor about abiraterone but was told it would cost me £42,000 as it wasn’t available on the NHS.

I felt everything I was asking for was no. The chemotherapy had taken my life away. All I wanted to do was find a corner, curl up and die.

I do not think I will live to April. How will my wife manage without me? We have been together for 42 years and have walked many roads together. This is the toughest walk that we have done together.

By March my PSA had gone up to 380 and was maybe still going up. The chemotherapy was not doing anything for me so I was taken off it, which was a great relief. I asked again for abiraterone and was told it was not available but my doctor wished it were.

The cancer had spread to most of the bones in my body. After meeting Keith again, I again asked my doctors for scans and abiraterone. My doctor agreed to write to the drug company to ask it to finance the abiraterone. The company agreed.

The doctor told me I was one of 19 people selected to try this drug, but he wasn’t sure it would do me any good. I didn’t not look fit enough to take it. He didn’t think it would improve my quality of life. I asked him to give me a chance.

I took my first dose of abiraterone on April 22, 2011; three weeks later I told my cancer specialist my life had changed 100% for the better. With the help of my son I changed and rewired the bathroom light, fitted an extractor fan in the bathroom, changed all the guttering and the down pipes on the house.

Although I’m not working as I used to be, I told him I was so glad I would do it. I still had the pain in my right hip but I was able to do all the work on my house that I had to leave before I went on chemotherapy. I could also drive again with all the confidence in the world.

I noticed the change just 24 hours after starting abiraterone – I was starting to get my quality of life back.

All the work on the house was finally finished 92 days after I’d started taking abiraterone – that’s how good this drug worked for me.

At a hospital appointment in July, my PSA level was down to 19 and my blood pressure was OK. I asked how long the abiraterone would last and was told it may last for 12 months. I have a life to live with what time I have. I do not have the time to sit and feel sorry for myself if this drug only lasts a year. I have things I want to do, places I want to go. A lot to do. I now live for the here and now, as I cannot plan the future.

The day that I was given abiraterone was a turning point for me. I was given another bite of the cherry. The drug does give me a few problems – my ankles swell up; I have a moon face and I’ve put on a lot of weight – but the price is worth it.

I’ve read articles from other men who were crying out to be given the chance that I have. I’m one of the lucky ones – if I had to pay for this drug I couldn’t have afforded it. The drug works for some but not for others, it worked for me.

To make my point on how well this drug has worked for me, I’m writing this in February 2012; in February 2011 I couldn’t write; I didn’t have a life, and no hope for a future. I am now once again me. I have hope and a future. I have a few bits and pieces not working; my old bones are clicking when I walk, and other things don’t work.

I will not pass an MoT. I will rust in a scrap yard, but I can live with that. I hope they don’t make use of me for spare parts.

Eddy Newman is 65 and lives in Cardiff

Zytiga Placebo Outperforms Provenge

Results from the latest Zytiga clinical trials show that patients on the placebo arm had a median overall survival (OS) of 27.2 months while the patients on the Zytiga treated arm had such a good survival time that the median value has not yet been reached.

It is interesting to compare the placebo arm OS time with that seen for Sipuleucel-T (Provenge) when it underwent clinical trials in the same class of patient population to establish its efficacy. The OS time for Provenge was found to be 25.9 months. The Zytiga placebo arm had an OS time of 27.2 months so this data taken together shows that under clinical trial conditions a placebo has a greater effect than Provenge.

Zytiga Reduces Pain

Johnson & Johnson (JNJ)’s prostate cancer pill Zytiga, currently given after chemotherapy fails, significantly slows tumor growth, prevents pain and lengthens life when used earlier before chemotherapy, researchers said.
Men treated with Zytiga plus steroids who had not received chemotherapy gained at least 16 months before the cancer resumed spreading, twice the 8 month progression-free survival seen in those given steroids alone, according to research presented at the American Society of Clinical Oncology meeting in Chicago. The benefits were so strong that a safety monitoring board stopped the study in March and recommended all men take Zytiga.

“Taking Zytiga earlier can help patients maintain their quality of life free of pain, reduce the need for chemotherapy and live longer,” said lead researcher Charles Ryan, an oncologist at the University of California, San Francisco, in a telephone interview.
About 30,000 men in the U.S. die from advance prostate cancer each year, according to the American Cancer Society. Because patients generally live for about three years with the disease, there are roughly 100,000 men with prostate tumors looking for treatment, Ryan said. The malignancy is the second most common cause of cancer death in men.

Delaying Chemotherapy

Bruce Roth, a professor of medicine at Washington University in St. Louis, said he has at least 100 patients who are putting off chemotherapy who could benefit from Zytiga. He said many patients delay chemotherapy as long as possible, even as their disease progresses, because of the side effects, which can include fatigue and neutropenia, a condition that increases the risk of infections.
“The pool of patients is very large,” Roth said. “There are patients who are waiting for something, but not willing to take on the toxicity of chemotherapy and decrease their quality of life.”
The findings could encourage doctors to start prescribing Zytiga even before it receives U.S. Food and Drug Administration clearance for use preceding chemotherapy, said Larry Biegelsen, an analyst at Wells Fargo Securities in New York, in a May 31 note to investors. His $525 million sales estimate for Zytiga in the U.S. this year may be too low, Biegelsen said. The drug is on track to generate $1.3 billion annually by 2015, he said.

Approval Plans

The company plans to request broader FDA approval in the second half of 2012, said Michael Meyers, Johnson & Johnson’s compound development team leader for Zytiga. It will also conduct another analysis of the study involving 1,088 men with spreading disease that hasn’t yet caused severe symptoms, after patients have been followed for a longer period, he said.
The study was stopped after an interim review of the findings. Because more deaths occurred in patients given only the steroid prednisone, the researchers were able to determine their median overall survival was 27 months, the longest ever seen in a study of patients with advanced prostate cancer. Survival exceeded that seen in earlier trials of Dendreon’s Provenge.
Men treated with Zytiga had a 25 percent reduction in their risk of death during the time the study was under way, Meyers said. Because it was halted early, the median overall survival for those given Zytiga hasn’t been reached. Additional follow up is needed to conclusively determine how much longer Zytiga patients live and whether the difference is meaningful.

Finding the Benefit

About half of the men in the group given only steroids and whose disease worsened subsequently got chemotherapy, and 10 percent of them were given Zytiga, Ryan said. The additional treatments may have helped them live longer and could make it difficult to distinguish the pre-chemotherapy survival benefit from the Johnson & Johnson drug, he said.
Most men with advanced prostate cancer say their goals are to keep pain at bay, function normally and delay the need for more toxic treatment, Ryan said. Zytiga helps with all three areas, he said.
“There is a highly significant delay in suffering from the disease,” he said. “We never reached a median time where all men had pain and needed opiates” to control it.

Zytiga Delays Chemo by 2 Years

The latest clinical results for Zytiga shows that it delays the time before chemotherapy is needed by over 2 years.

The results show

• Median time to initiation of chemotherapy was
• 25.2 months in the abiraterone + prednisone arm of the trial
• 16.8 months in the placebo + prednisone arm of the trial

Zytiga Effective Pre Chemotherapy

The results from the latest Phase 3 clinical trial on Zytiga pre chemotherapy are clear cut - there is a progression free survival increase (PFS) and a trend towards overall survival (OS). The exact extent of OS for Zytiga could not be determined since the mean OS has not been reached in the Zytiga arm of the study due to the actual extent of OS. The OS of the placebo arm was 27 months and for Zytiga was longer than this but how much longer we will not know since the trial has been completed. Dr Ryan estimates the OS to be about 33% which is a 9 month extension of life.

Here is the Abstract presented by Ryan et al at the ASCO meeting in Chicago on 2 June 2012

Interim analysis (IA) results of COU-AA-302, a randomized, phase III study of abiraterone acetate (AA) in chemotherapy-naive patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Abstract:

Background: AA is an androgen biosynthesis inhibitor that inhibits CYP17 and improves overall survival (OS) in post-docetaxel mCRPC. The primary objective of COU-AA-302 was to compare clinical benefit of AA + prednisone (P) vs placebo (PL) + P in chemo-naive, asymptomatic/mildly symptomatic mCRPC pts.

Methods: 1088 pts (151 centers; 12 countries) were randomized 1:1 to AA (1 g) + P (5 mg BID) or PL + P. Co-primary endpoints: radiographic progression-free survival (rPFS) and OS. Median times estimated using K-M method including LR statistic for inference. The Lan-DeMets α-spending function was used for OS.

Results:The Independent Data Monitoring Committee concluded that the OS, rPFS and secondary endpoints (Table) all favored the AA arm and unanimously recommended unblinding the study and crossing pts from PL to AA at IA (43% of total events). Median follow up = 22.2 mos. Grade 3/4 AEs (AA + P, PL + P) (%): hypertension 3.9 vs 3.0; hypokalemia 2.4 vs 1.9; ALT↑ 5.4 vs 0.7; AST↑ 3.0 vs 0.9.

Conclusions:AA + P produced a statistically significant improvement in rPFS and a strong trend for increased OS at this IA. AA resulted in clinically and statistically significant effects on all secondary endpoints. IA results confirmed the acceptable tolerability/safety profile of AA. This is the first randomized trial to demonstrate both OS and rPFS benefits in chemo-naive mCRPC and that inhibition of persistent extragonadal androgen synthesis significantly delays initiation of cytotoxic chemo. While median OS (AA arm) has not been reached, median PL arm OS (27.2 mos) is the longest measured in any phase III mCRPC study.

	AA + P (median, mos)	PL + P (median, mos)	HR (95% CI)	P
rPFS*	NR	8.3	0.43 (0.35, 0.52)	<0.0001
OS†	NR	27.2	0.75 (0.61, 0.93)	0.0097
Time to opiate use (cancer-related pain)	NR	23.7	0.69 (0.57, 0.83)	0.0001
Time to chemotherapy initiation	25.2	16.8	0.58 (0.49, 0.69)	<0.0001
Time to ECOG-PS deterioration	12.3	10.9	0.82 (0.71, 0.94)	0.0053
Time to PSA progression	11.1	5.6	0.49 (0.42, 0.57)	<0.0001

Abbreviation: NR, not reached.