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Sandeep Singh Dhillon
Roche Cancer Drug Rises To Challenge Merck, Bristol-Myers – Forbes
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By Matthew Herper

Tecentriq, a cancer immunotherapy developed by the Swiss drug giant Roche, slowed the progression of previously untreated lung cancer in a large clinical trial when combined with a chemotherapy regimen, the drug giant said.

“We are extremely encouraged by these results and will submit these data to health authorities globally with the goal of bringing a potential new standard of care for the initial treatment of lung cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer said in a press release

The news represents the latest upset among a class of new medicines that unlock the body’s ability to fight tumors. These medicines, called PD-1 inhibitors, are already big sellers for Bristol-Myers Squibb and Merck. In the third quarter of 2017, Bristol’s Opdivo generated $1.3 billion in sales; Merck’s Keytruda generated $1 billion. Financial analysts at Wall Street banks forecast that by 2022, these drugs will generate annual global sales of $25 billion a year, with the bulk of sales going to Bristol and Merck.

Merck has pulled ahead of Bristol, the pioneer in developing these drugs, because an early Merck trial in first-line lung cancer succeeded, while a similar study from Bristol failed, baffling investors and researchers. Keytruda is approved in advanced non-small lung cancer in patients whose tumors express a protein called PD-L1 above a certain level, or in combination with the chemotherapy drugs Alimta and carboplatin. Today’s Roche result complicates things further, because Roche used a different combination of drugs

Roche’s study had three arms. All patients received carboplatin and paclitaxel, the cancer drug once sold as Taxol. The control group also received Avastin, one of Roche’s best-selling cancer drugs. Then two groups got Tecentriq, one with Avastin and one without. What Roche has announced today is that the Avastin-Tecentriq-chemotherapy combination did better than Avastin and chemotherapy alone, and that the survival results so far are “encouraging.” That leaves a big question: how are the patients who got Tecentriq, but not Avastin, doing?

It’s impossible to know exactly what this will mean until the full results of the study are presented. (Companies release early results by press release because they are considered too important to investors to keep secret.) In morning trading, Roche shares are up as much as 5.6%, and Merck shares are down 2%. But two analysts, Umer Raffat of Evercore/ISI and Timothy Anderson at Bernstein Research. commented that the results could actually be seen as a validation of the general Merck approach of combining PD-1 drugs with chemotherapy. Rivals, including Bristol and AstraZeneca, have favored combining them with another type of immunotherapy drug, called a CTLA4 inhibitor, such as Bristol’s Yervoy.

One big question will be how the chemotherapy regimens stack up against the CTLA4 combinations. Another will be how they stack up against each other. How will doctors compare the Merck and Roche drug regimens? How will insurance companies decide which ones to cover? Anderson, the Bernstein analyst, said that investors are likely to not view Roche as a big threat because it is entering the market late. But he also wrote that the trial is “one important piece of a complex, still largely incomplete, puzzle.” Bernstein forecasts 2022 Tecentriq sales of $3.7 billion, less than half as much as for Opdivo or Keytruda.

New Immune Therapy Drug Gives Bladder Cancer Patients Fresh Hope – NBCNews
Pharma News, Pharma Notables

A newly approved drug that gives the immune system a boost helped stall the spread of tumors in patients with advanced bladder cancer, researchers reported Sunday.

It’s not a slam-dunk, but it’s another piece of good news for the latest approach to treating cancer by harnessing the body’s immune system.

The drug, called atezolizumab and sold under the brand name Tecentriq, works in a similar way to Keytruda — the drug credited with stopping former president Jimmy Carter’s advanced melanoma.

In the study, the treatment stopped tumors from growing in 24 percent of the advanced bladder cancer patients, and shrank them by 30 percent, the team told a meeting of the American Society for Clinical Oncology in Chicago.

“Immunotherapy really treats your body’s immune system so your immune system can fight the cancer for you,” said Dr. Arjun Balar, an assistant professor at NYU Langone Medical Center who treated some of the patients.

Earlier immune therapy approaches to cancer involved revving up the immune system, but it did not always work very well and caused some unpleasant side effects.

Other, more successful approaches, involve training immune cells to recognize a patient’s specific tumors, or finding and amplifying a patient’s own tumor-specific immune cells. They’re labor-intensive and don’t work for everyone.

The new drugs act directly on the immune cells that are supposed to destroy tumors. These monoclonal antibodies – very precisely targeted molecules – stop a genetic interaction that allows cancer cells to evade the immune cells. They’re called checkpoint inhibitors.

Tecentriq won Food and Drug Administration approval last month.

Here’s the tricky part. The drug is priced at $12,500 a month.

It’s a price that drug makers say is fair, given how well it saves lives and given its cost of development, but the increasingly sky-high prices of cancer drugs has become controversial.

“Our new study results argue that atezolizumab represents a major advance in the treatment of bladder cancer,” Balar said.

The researchers say 21 out of the original 119 patients treated starting in 2014 are still in remission and still taking the drug.

“Atezolizumab is the first therapy to be approved in more three decades for this disease, and it is the new standard of care for patients whose initial therapy with platinum-based chemotherapy drugs has failed,” he added. “Indeed, it may be the only therapy some patients need.”

As with most experimental drugs, Tecentriq had already been tested in patients who had tried all the best available treatments first. For this study, it was the first drug that patients got. They were not eligible to get the standard treatment for various reasons.

Right now, the platinum-based cisplatin is the main treatment for advanced bladder cancer. But it can damage nerves and the kidneys.

“Most patients who received atezolizumab really had no side effects whatsoever,” Balar said. Side-effects were mild and included fatigue, itchy skin, and diarrhea. But other research on checkpoint inhibitors suggest they can sometimes set off an attack on healthy organs, so researchers are testing them cautiously.

Balar wonders if the drugs might work even better if given to bladder cancer patients straight away, and to those with earlier-stage disease.

“Can we use this treatment earlier in the course of the disease?” Balar asked.

Other studies on similar drugs suggest that genetic tests can predict which patients will be helped by the checkpoint inhibitors, and trials are under way to see.

According to the American Cancer Society, 76,960 new cases of bladder cancer will be diagnosed this year – most of them in men. Bladder cancer will kill more than 16,000 Americans this year. “Bladder cancer accounts for about 5 percent of all new cancers in the US. It is the fourth most common cancer in men,” the group says.

Virtually all patients diagnosed at the earliest stage, stage 0, survive. But stage IV bladder cancer, which means it has spread to other parts of the body, kills 85 percent of patients within five years.