New Immunotherapy Drug Data Show Promise in Treating Cancer; Drugs From Bristol-Myers and Merck Shown to Prolong Lives of Some Cancer Patients

New Immunotherapy Drug Data Show Promise in Treating Cancer

Drugs From Bristol-Myers and Merck Shown to Prolong Lives of Some Cancer Patients


June 2, 2014 7:30 a.m. ET

Drugs designed to unleash the body’s own immune system against cancer are significantly prolonging the lives of some people with hard-to-treat forms of the deadly disease. WSJ’s Jeanne Whalen joins Tanya Rivero on Lunch Break to explain. Photo: Getty

CHICAGO—Drugs designed to unleash the body’s own immune system against cancer are significantly prolonging the lives of some people with hard-to-treat forms of the deadly disease.

The latest evidence: Patients with the skin cancer melanoma who received a combination of two Bristol-Myers Squibb Co. BMY -1.31% immunotherapies in a clinical trial lived an average of more than three years, researchers reported Monday. In another study, about 70% of advanced melanoma patients receiving aMerck MRK +0.12% & Co. immunotherapy were still alive after one year of treatment.

Doctors say the outcomes were impressive because until recently, most patients with advanced melanoma could be expected to live for less than a year.

These findings and others being presented Monday at the annual meeting of the American Society of Clinical Oncology add to growing enthusiasm among cancer doctors that immunotherapies could usher in a major advance in treatment not just for melanoma, but also for a range of cancers including those of the lung, bladder and kidney.

Doctors have known for a few years that the new batch of immunotherapy drugs can shrink hard-to-treat tumors in a significant percentage of patients. But the latest survival data show the effect appears to be lasting in many patients. In contrast, some other classes of cancer drugs including chemotherapy and even the newer agents that target genetic mutations underlying the growth of tumors often stop working after tumors develop resistance. Researchers believe the immunotherapy drugs can trigger an “immunological memory” that keeps tumors in check, sometimes long after treatment.

“You have a remarkable change in the natural history of their cancer,” Louis M. Weiner, director of the Georgetown Lombardi Comprehensive Cancer Center in Washington, said during an interview at the meeting. “We are on the verge of being able to manipulate the body’s immune response against cancer so the body itself will take care of the cancer.”

Still, there was reason for caution with the new approach. One new study showed that giving Bristol-Myers’s Yervoy immunotherapy to patients after surgical removal of early-stage melanoma could reduce the risk of disease recurrence by 25%, but it came with a high cost: side effects so severe they caused half the patients to discontinue treatment, and five patients died from treatment-related conditions. Another study of lung-cancer patients showed that combining Yervoy with Bristol’s experimental immunotherapy nivolumab also had a high rate of serious side effects.

Some doctors stressed that much of the clinical data for immunotherapies were from early to midstage trials, and need to be tested against comparators in later-stage studies. Also, some doctors question whether the drugs will prove cost-effective in light of the high price tag for Yervoy, at $120,000 for a standard course of treatment, and the potential for similarly high costs for the next wave of immunotherapies.

“The melanoma stuff is a game-changer,” said Derek Raghavan, president of the Levine Cancer Institute at the Carolinas HealthCare System, Charlotte, N.C. But as drug companies and researchers seek to build the case beyond initial successes to other tumors, doctors and payers will ask, “Is it a breakthrough and if it is, how big a breakthrough?” he said. “If it’s not a big enough breakthrough, is it worth the money?”

Yervoy, which was introduced in 2011, is approved for melanoma that has spread to other parts of the body or is inoperable. It can cause severe side effects associated with an overactive immune system, including the gastrointestinal disorder colitis. Doctors say the side effects of Yervoy can be alleviated with steroids and other therapies, or by temporarily discontinuing Yervoy. Yervoy alone is associated with a median overall survival of 10 months, though in clinical studies, more than 20% of patients were still alive after three years.

A newer class of drugs targets a component of immune-system cells known as PD-1, for programmed death receptor 1, which acts as a brake on the immune system to prevent it from attacking healthy cells. Cancer cells can exploit the mechanism by latching on and using PD-1 to escape destruction by the body’s immune system.

Bristol-Myers’s experimental PD-1 inhibitor nivolumab and Merck’s candidate, pembrolizumab, block PD-1, allowing the immune system to attack the cancer cells. Roche Holding AG ROG.VX +1.86% and AstraZeneca AZN.LN +2.03% PLC have similar drugs in development, all racing to tap what is expected to be a multibillion-dollar market. Merck’s drug was previously code-named MK-3475.

One evolving strategy is to combine drugs to see if they work better than single drugs. Bristol tested a combination of various dose levels of nivolumab and Yervoy in more than 50 patients with advanced melanoma. Some 41% experienced tumor shrinkage. The median overall survival was nearly 40 months, and 79% were still alive two years after start of treatment. At the dosing regimen that is being used in a subsequent continuing study, the two-year overall survival rate was 88%.

More than 50% of patients experienced high-grade adverse events, including colitis.

Mario Sznol, a professor of medical oncology at Yale Cancer Center in New Haven, Conn., who is presenting the study results at the conference, said the combination’s “risk-benefit ratio seems acceptable.” Bristol is conducting a larger, late-stage study in melanoma patients comparing the combination against either drug alone, which is expected to be completed in 2016. The company has begun the application process to the U.S. Food and Drug Administration for approval of nivolumab alone to treat a form of lung cancer, which it expects to complete by the end of this year.

Merck tested pembrolizumab in more than 400 patients with advanced melanoma, including some who were previously treated with Yervoy. Some 34% of patients experienced tumor shrinkage, and about 70% were alive after one year.

“The key thing is the high frequency of durable responses,” said Antoni Ribas, director of the tumor immunology program at the Jonsson Comprehensive Cancer Center, University of California, Los Angeles. “Typically, the results wane. Here they are staying.”

Merck has applied for U.S. Food and Drug Administration approval to sell pembrolizumab as a treatment for advanced melanoma in patients whose disease has progressed after taking Yervoy. An agency decision is expected by late October.

“This field has spent several decades figuring out better ways to treat the cancer, and very important accomplishments have been made,” said Jedd D. Wolchok, chief of the melanoma and immunotherapeutics service at Memorial Sloan Kettering Cancer Center in New York. “We now have a way to treat the patient as well. With immunotherapy, you’re treating the patient, and the patient is treating the cancer.”


About bambooinnovator
Kee Koon Boon (“KB”) is the co-founder and director of HERO Investment Management which provides specialized fund management and investment advisory services to the ARCHEA Asia HERO Innovators Fund (, the only Asian SMID-cap tech-focused fund in the industry. KB is an internationally featured investor rooted in the principles of value investing for over a decade as a fund manager and analyst in the Asian capital markets who started his career at a boutique hedge fund in Singapore where he was with the firm since 2002 and was also part of the core investment committee in significantly outperforming the index in the 10-year-plus-old flagship Asian fund. He was also the portfolio manager for Asia-Pacific equities at Korea’s largest mutual fund company. Prior to setting up the H.E.R.O. Innovators Fund, KB was the Chief Investment Officer & CEO of a Singapore Registered Fund Management Company (RFMC) where he is responsible for listed Asian equity investments. KB had taught accounting at the Singapore Management University (SMU) as a faculty member and also pioneered the 15-week course on Accounting Fraud in Asia as an official module at SMU. KB remains grateful and honored to be invited by Singapore’s financial regulator Monetary Authority of Singapore (MAS) to present to their top management team about implementing a world’s first fact-based forward-looking fraud detection framework to bring about benefits for the capital markets in Singapore and for the public and investment community. KB also served the community in sharing his insights in writing articles about value investing and corporate governance in the media that include Business Times, Straits Times, Jakarta Post, Manual of Ideas, Investopedia, TedXWallStreet. He had also presented in top investment, banking and finance conferences in America, Italy, Sydney, Cape Town, HK, China. He has trained CEOs, entrepreneurs, CFOs, management executives in business strategy & business model innovation in Singapore, HK and China.

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