I thought it would be good to bring together all I knew about the man behind Keytruda.
Merck has really worked hard at this and to think when a man sat in his Laboratory and first made this drug, with the help of mice, he put it to one side and didn’t know what to do with it until another scientist found it on the shelves of a fridge and realised just what it could do. Amazing !!!
The Latest report from Merck that Keytruda is being passed for Lung Cancer so adding another cancer to the list with Melanoma had me thinking about the origins of the wonder drug
Merck’s flagship cancer immunotherapy Keytruda delayed the re-growth of tumors and prolonged survival in patients with newly diagnosed non-small cell lung cancer compared to chemotherapy, the company said Thursday.
Gregory J. Carven Ph.D.
Vice President of Antibody Discovery and Protein Sciences, Scholar Rock, Inc.
|Age||Total Calculated Compensation||This person is connected to 0 Board Members in 0 different organizations across 1 different industries.|
Pembrolizumab was invented by Gregory Carven, Hans van Eenennaam and John Dulos at Organon Biosciences. MRC Technology humanized the antibody pembrolizumab for Organon in 2006.
On September 4, 2014 the US Food and Drug Administration (FDA) approved pembrolizumab under the FDA Fast Track Development Program. It is approved for use following treatment with ipilimumab, or after treatment with Ipilimumab and a BRAF inhibitor in advanced melanoma patients who carry a BRAF mutation. It is marketed by Merck.
On October 2, 2015, the FDA approved pembrolizumab for the treatment of metastaticnon-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and who have failed treatment with otherchemotherapeutic agents.
Pembrolizumab was priced at $150,000 per year when it launched.
Mechanism of action
Pembrolizumab is a therapeutic antibody that blocks the inhibitory ligand of programmed cell death 1 receptor located on lymphocytes. This receptor is responsible for inhibiting the immune response to cancer cells which express programmed death-ligand (PD-L1 or PD-L2). Normally, this effect is necessary to avoid inappropriate overreaction, such as an auto-immune disease, in healthy individuals. In cancer patients antibody blockade against this receptor such as with Pembrolizumab reinvigorates the immune system, allowing it to target and destroy cancer cells. Pembrolizumab is one of a number of closely related therapies dubbed checkpoint therapy.
As of 2015 a large phase I clinical trial produced response rates of 37–38% in patients with advanced melanoma and an overall response rate of 26% in patients who had progressive disease after treatment with Ipilimumab.
The KEYNOTE-012 phase IB study is testing pembrolizumab for triple-negative breast cancer (TNBC), gastric cancer, urothelial cancer, and head and neck cancer. It reported encouraging interim results (eg in TNBC) in 2016. The ongoing phase II KEYNOTE-086 study is evaluating a 200-mg dose of pembrolizumab, given once every 3 weeks, in patients with TNBC.
The Fred Hutchinson Cancer Research Center has tapped well-known drug investigator Gary Gilliland to become its new president. Beginning on the first work day in January, Gilliland, who recently completed a stretch at Merck ($MRK) as head of oncology drug research, will take the helm of one of the country’s top cancer research institutes. Among other things, the Hutch has played a leading role in launching the CAR-T and TCR player Juno, which is now going public. Gilliland’s lengthy resume includes a professorship at Harvard University and a stint at the Howard Hughes Medical Institute. And he says the timing is right to focus on new ways to cure cancer. “This is the perfect time and perfect place to develop curative approaches for cancer,” said Gilliland, a physician-scientist. “Everything I’ve done in my career has pointed here.” Release
Then this story emerged around the world and we became interested in Keytruda But by this stage I was on the trial MK3475-28 after hearing so much about the drug for sometime through Immunotherapy was becoming the in word. The treatment that was going to give Mesothelioma the cure. Little did I know that I would be playing such a huge role in the story.
Formula One Melbourne Grand Prix: Race supremo Ron Walker beats cancer
Ron Walker is satisfied he has beaten the cancer that 2½ years ago riddled his body. Photo: Chris Hopkins
Australian Grand Prix supremo Ron Walker has been declared cancer-free after a nearly three-year fight for his life.
As he prepares for his final Albert Park Formula One race as chairman of the Australian Grand Prix Corporation, Walker revealed his remission was confirmed late last year following treatment with an experimental drug in the US.
He was satisfied he had beaten the cancer that 2½ years ago riddled his body, because scans and blood tests had cleared him of the malignant disease.
“The doctors in America announced me to be cancer-free 12 weeks ago, so I’m the luckiest guy that ever walked,” Walker told Fairfax Media.
His recovery has defied a grim diagnosis by the Peter MacCallum Cancer Centre in November 2012 that he would not make Christmas that year because radiation treatment and a conventional immunotherapy drug had failed to arrest the cancer.
“They said at Peter MacCallum that they never thought they’d see this result in their lifetime, so I must’ve done something right,” Walker said. “I’m very lucky it’s gone. It was in my brain, my bones, my lungs, my heart, everything.”
Walker, 75, was found to have a melanoma on his forehead in February 2012, but late that year the skin cancer had spread throughout his body.
Along with an adverse reaction to a local drug treatment, the life-threatening extent of the cancer drove him to secure a place in a trial for a new immunotherapy drug called Keytruda in Los Angeles.
“If I had stayed in Melbourne and just done nothing, I wouldn’t be here today talking to you, because the drug they offered me was shocking,” Walker said. “I really am genuinely grateful that my life was saved.”
While he was wealthy enough to afford the regular trips to LA in 2013-14 and the cutting-edge drug treatment, which he admitted “wasn’t cheap”, he campaigned to have Keytruda approved in Australia at an affordable cost to cancer patients.
The former lord mayor of Melbourne and long-time federal Liberal Party grandee has successfully lobbied Canberra for the drug – which was fast-tracked onto the American market last September – to be available in Australia on the Pharmaceutical Benefits Scheme.
“It’s given hope to people who thought they were going to die,” Walker said. “Now they’re not going to die. It’ll be available in the middle of March to everybody.”
He said prevailing on his Liberal Party contacts in the federal government, including Prime Minister Tony Abbott, to make Keytruda available and affordable to everyone was his way of helping other less fortunate cancer victims.
“People were dying around me and their parents were ringing me up or their wives were ringing me up, saying, ‘My husband has stage-four melanoma, what can you do to help?’ Well, I couldn’t do anything to help unless I got the drug at the right price through cabinet.”
Walker, who will step down as chairman of the AGPC after 20 years following Sunday’s F1 season-opener at Albert Park, dismissed his fortune – estimated to be in the hundreds of millions of dollars – as the live-or-die difference.
“Leave the money aside,” he said. “I could’ve got a cheap air ticket. If I didn’t have a dollar, I still would’ve gone on a cheap flight somehow.
“If I had’ve been a normal guy on the street, I would’ve mortgaged something if I had something to mortgage – or borrowed the money from a mate.”
However, Walker conceded his connections in high places, made during nearly three decades negotiating major event deals for Victorian governments of both political persuasions, opened doors for him to get into the US trials of Keytruda.
“I was just lucky enough over the years to accumulate a lot of contacts,” he said.
With the backing of then premier Jeff Kennett, Walker was instrumental in “stealing” the Australian Grand Prix from Adelaide in 1993, with Melbourne taking over the race at the revived Albert Park lakeside circuit – used for international motor races in the 1950s – in 1996.
Although his battle with cancer has taken its toll on his 198-centimetre frame and left his once luxuriant head of red hair grey and wispy, he never lost his commitment to the grand prix.
“Working for Ron in that period of time, nothing’s changed as far as his continued passion for the event, and the ideas and the frequency of those ideas,” AGPC chief executive Andrew Westacott told Fairfax Media.
“He continued to put Melbourne first and the grand prix first, and all the ideas that are going to be making the event better than any event on the F1 calendar.”
Walker expressed confidence that his successor as chairman of the AGPC would guide the organising team to maintain the high standard of the race, which was last year renewed from 2016 to 2020.
“Whoever follows me will do as good a job, if not better,” he said. “I’m very proud of the succession program.”
Read more: http://www.smh.com.au/sport/motorsport/formula-one-melbourne-grand-prix-race-supremo-ron-walker-beats-cancer-20150312-142bh2.html#ixzz4C0Ztk1TA
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I had been invited to iMIG conference and Prof Dean Fennel wanted me to Announce my results at this point so I hang back as long as I could. My Blog tells the rest of the story
Merck’s (MRK) flagship cancer immunotherapy Keytruda delayed the re-growth of tumors and prolonged survival in patients with newly diagnosed non-small cell lung cancer compared to chemotherapy, the company said Thursday.
The new phase III study results from Merck are significant because they represent the first time that a drug belonging to the so-called checkpoint inhibitor class of cancer immunotherapies has demonstrated superiority over standard of care in the treatment of first-line lung cancer patients.
Lung cancer is the most prevalent cancer globally, with more than 200,000 patients in the U.S. and 1.5 million patients globally diagnosed each year. As such, lung cancer is an important commercial market for the drug companies developing new therapies which harness the immune system to target and kill cancer cells.
Cancer immunotherapy sales will reach $34 billion to $35 billion by 2026, of which almost half will come from lung cancer, predicts Leerink, the health care investment bank.
Merck is the first of the Big Pharma companies to demonstrate the efficacy of a checkpoint inhibitor in newly diagnosed lung cancer, but it will likely have company soon.
Bristol-Myers Squibb (BMY) is expected to announce results from a phase III study of Opdivo in first-line lung cancer in the third quarter. Roche (RHHBY) is also making an aggressive push with its own checkpoint inhibitor into lung cancer.
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For now, Merck is not saying much about how well Keytruda performed in the phase III, study known as Keyote-024. The study compared Keytruda against a doublet chemotherapy in patients with non-small cell lung cancer who had not yet received any systemic therapy.
Keytruda beat chemotherapy on the study’s primary endpoint of progression-free survival and the secondary endpoint of overall survival, the company said. The magnitude of Keytruda’s benefit was not disclosed Thursday, but Merck said the data are strong enough to support approval filings in the U.S. and Europe.
Importantly, the patients enrolled in Merck’s Keytruda study also had to have lung cancers that expressed high levels of the protein PD-L1, defined as a tumor proportion score of 50% or more.
Checkpoint inhibitors like Keytruda and Opdivo work by blocking the interaction between PD-L1, a protein found on the surface of tumor cells. with PD-1, a receptor found on immune cells. Blocking the PD-1/PD-L1 connection allows a patient’s immune system to recognize and kill cancer cells.
Bristol is enrolling a larger, more inclusive group of first-line lung cancer patients with tumors expressing lower levels of PD-L1 in its studies of Opdivo. Depending on the study results, this may give Bristol a competitive advantage in the commercial market.
That’s what has already happened in the treatment market for more advanced, second-line lung cancer, where Bristol enjoys a significant market share advantage over Merck.
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