The OBR Blog

November 25, 2013 - 06:11 am Posted in Featured comments2 Comments

As we leave Lung Cancer Awareness Month, we thought you might like to review the lung cancer headlines we’ve seen in OBR so far in 2013.

Importantly, and perhaps most controversially, in July we received another draft recommendation from the U.S. Preventive Services Task Force (USPSTF) on screening, this time for lung cancer and aimed primarily at heavy smokers.  If it’s adopted as the standard of care in medical practice for people at-risk, annual low dose computed tomography (CT) screening could save lives by finding lung cancer sooner when it’s still treatable.  But it’s not without controversy.  Read on to find out more.

1) Pipeline Hits

Some of the most talked-about drugs in the pipeline for lung cancer in 2013 were the PD-1/PD-L1 next generation immunotherapies:  Merck’s MK-3475, Bristol Myers-Squibb’s nivolumab and Roche’s MPDL3280A. They’re a class of compounds designed to disable the ‘”programmed death 1’” proteins called PD-1 and PD-L1 that prevent the immune system from spotting and attacking cancer cells.

In a European Cancer Congress (ECC) presentation in September, in an early stage trial of 53 patients with non-small cell lung cancer (NSCLC) whose tumors were treated with MPDL3280A, 23% saw their tumors shrink. The response rate for smokers was even more encouraging—26% compared with 10% for patients who had never smoked.  Roche’s PD-L1 inhibitor was called a potential “game changer” in lung cancer as the first targeted drug to show more activity in a difficult-to-treat group of smokers than non-smokers.

At the World Conference on Lung Cancer (WCLC) in October, Bristol Myer-Squibb released additional survival data from an early stage study of pre-treated patients with NSCLC on nivolumab, showing that it extended the lives of lung cancer patients.  Forty-two percent of treated patients were alive after a year, and 24% after two years.

Merck’s MK-3475 showed positive results in early data from a small trial which was also presented at WCLC. Out of 38 patients in the study whose cancer had stopped responding to earlier rounds of treatment, 24% had an immune-system response to MK-3475 and 21% of patients experienced tumor shrinkage.

In August, Eli Lilly and Co. said that necitumumab, or IMC-11F8, combined with standard chemotherapy agents, had extended overall survival in a late-stage study of patients with the “squamous” form of NSCLC that had spread to other parts of the body.  The company plans to seek U.S. approval for necitumumab as a first-line treatment in 2014.   And Lilly’s ramucirumab, which improved survival in a late-stage trial of stomach cancer, is now in late-stage trials for lung and other cancers.

Then there’s ARIAD’s AP26113, which has a good chance of being approved for ALK-driven lung cancer; and Novartis’ two promising new compounds, AUY922 and LDK378, which might also treat ALK-mutated lung cancers.  The list for lung cancer therapies in the pipeline doesn’t end there…

2) Screening Those At-Risk

Smoking accounts for about 85% of lung cancers and there was evidence this year that annual screenings for people with a history of smoking might save lives.  In July the USPSTF recommended that current and former smokers between 55 and 70 with a history of smoking a pack a day for 30 years or more, as well as those who quit within the last 15 years, get annual screenings with low dose computed tomography (CT). Experts said that 20,000 of the 160,000 annual deaths from lung cancer could be avoided if the guidelines were adopted.

The task force weighed the benefits of early cancer detection against its risks for patients. Those risks included the exposure to radiation from the CT scans and the number of false positives the scans might turn up, which could lead to overtreating patients.  Some experts were also concerned that the screening recommendation might send the wrong message to people, i.e., that it’s okay to smoke.

In September, two new studies published in the New England Journal of Medicine made a good case for the task force’s recommendation.  Researchers found that annual lung cancer screenings with low dose CT scans could successfully detect malignant tumors before they spread to other parts of the body.  And annual screenings over a three year period using CT scans not only caught more early stage lung cancers than chest X-rays, but improved the ability to accurately detect cancer from year to year.

The current draft recommendation is in sync with the American Society of Clinical Oncology (ASCO), the National Comprehensive Cancer Network (NCCN) and other organizations, which have been recommending lung cancer screening with low dose CT scans for those at-risk since May 2012.  With the Affordable Care Act in play, Medicare and other insurers would have to cover the scans for eligible patients without any co-pay or deductible.

The public comment period ended August 26 and the final recommendation from the task force is expected at any time.

3) E-cigarettes, Kids & the FDA

Twice as many U.S. middle and high school students used electronic, or e-cigarettes, which mimic traditional cigarettes and deliver nicotine as a vapor, in 2012 than the year before, the Centers for Disease Control and Prevention (CDC) said  in September.  The government report warned that the increasing use of hookahs, cigars and e-cigarettes, which are not yet subject to FDA regulation and can be flavored like fruit or candy, is a gateway for young people to a lifelong addiction and the use of stronger tobacco products. The public health threat was seen as so troublesome that the USPSTF recommended in August that physicians counsel teens and adolescents about the dangers of tobacco and smoking during routine office visits.  Anti-smoking advocates and public health groups said that the FDA hasn’t moved fast enough in issuing regulations on these additional tobacco products.

4) Air That Could Kill You

Another carcinogen was officially identified in 2013 as a leading cause of lung cancer, and this year it was the very air we breathe. In October the World Health Organization (WHO) officially classified air pollution as a human carcinogen. The risk, WHO said, was the same as breathing in second-hand smoke. Air pollution would be classified among other Group 1 human carcinogens and cancer-causing substances like tobacco smoke, asbestos and ultraviolet radiation.

News reports came in from around the world of an 8-year-old girl in Jiangsu province who was the youngest person on record in China to have been diagnosed with lung cancer—the country’s air pollution was blamed as the culprit.

5) FDA Activity

Let’s not forget about several FDA approvals this year for lung cancer.

Boehringer Ingelheim’s Gilotrif® (afatinib), was approved on July 12  for patients with late stage (metastatic) NSCLC whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.

On May 14, the cobas EGFR Mutation Test (Roche) became the first FDA-approved companion diagnostic to detect EGFR gene mutations and is intended for use with Tarceva® (erlotinib).  Roche’s drug won an expanded use as a first-line treatment for patients with NSCLC whose cancer has metastasized and who have EGFR gene mutations.

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