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After decades of hope and promise, the era of personalized cancer care has arrived. Targeted medicines and immunotherapies are now mainstays of treatment for a large share of patients with melanoma, lung, blood and breast cancers. New clinical trial results and FDA approvals are happening at an unprecedented pace and a growing majority are for personalized medicines.

And yet, not all patients who could benefit from these treatment advances are receiving them. One of the biggest reasons is that many are still not tested for biomarkers that can inform and personalize their treatment. Among physicians, researchers, and patients alike, this lack of testing is now viewed as one of oncology’s most urgent challenges.

“We are on the cusp of delivering personalized care to far more people with cancer,” said Dr. Charles Fuchs, who heads oncology and hematology product development at Genentech and Roche. “But to do that, we have to immediately tackle the challenge of getting everyone tested for the underlying drivers of their disease so we have a better understanding of which treatments are right for which patients.”

Personalized cancer care hinges on biomarkers

Identifying biomarkers in a patient’s tumor tissue or blood is an essential step in developing a personalized treatment plan, which might include targeted medicines or immunotherapies.

Lung cancer offers a perfect example. For non-small cell lung cancer (NSCLC), the most common form of the disease, more than FDA-approved 20 targeted therapies are now available to target specific genomic alterations in cancer cells.1 While any single genomic alterations say, in the ALK or ROS1 genes may be present in only a small percentage of patients, about 2 in 3 patients with metastatic NSCLC have at least one “actionable” biomarker, meaning there are FDA-approved treatments available that target the genomic alteration in their cancer cells.2 Many may also benefit from “checkpoint inhibitors,” medicines that may be able to enable the body’s immune system to recognize and attack tumors by targeting  certain proteins that can be present on a person’s immune cells. Immunotherapies may also affect healthy cells, which is why our scientists are committed to studying them further.

The value of this personalized treatment approach has been demonstrated in an array of research. In an observational study of nearly 18,000 patients with advanced NSCLC, for example, results from biomarker testing impacted treatment decisions for a little more than half of patients who had at least one actionable biomarker. Use of targeted therapies was associated with improved clinical outcomes among those with an actionable biomarker than when an actionable biomarker was absent.3

Yet only about three-quarters of patients with NSCLC receive any biomarker testing, according to a recent analysis by Flatiron Health.4 Fewer than half received comprehensive testing looking for all potentially relevant biomarkers using next-generation sequencing (NGS), a finding echoed by research from the MyLUNG consortium.5

“Slow uptake of comprehensive biomarker testing is one of the country’s most serious hurdles to personalized care,” said Dr. Fuchs of Genentech, which collaborated on both studies of testing rates. “And this has a real impact on patients it means lost opportunities for targeted therapy, along with frustration, uncertainty, and potentially poorer outcomes.”

Next-generation sequencing critical to progress

There are multiple reasons for today’s biomarker testing gaps, including lack of awareness, inadequate insurance coverage, and practical challenges such as long turn-around times for results.

Genentech is among the organizations working to address these hurdles for example, by supporting LUNGevity’s No One Missed campaign to help empower patients to request comprehensive biomarker testing after a lung cancer diagnosis, and participating in the MYLUNG Consortium, which aims to identify barriers to testing and develop practical strategies to overcome those obstacles. The company is also partnering with patient advocates, led by the American Cancer Society Cancer Action Network, to educate policymakers about the clinical and cost-effectiveness case for biomarker testing, so they can take action on insurance gaps and other barriers to equitable access.

According to Dr. Fuchs and others, next-generation sequencing is essential to solving these challenges. NGS, in fact, is already recommended for certain cancers by the National Comprehensive Cancer Network in its widely respected clinical guidelines for NSCLC.6

“Historically there’s been some skepticism that patients really need next-generation sequencing, but that point of view doesn’t hold up anymore,” said Dr. Fuchs. “We’re now at the point where patients and their doctors need to know all of their relevant biomarkers at the outset, so they can choose the most appropriate therapy or get connected to a suitable clinical trial.”

While NGS typically involves greater up-front costs than tests for individual biomarkers, research suggests that its cost is offset by avoiding wasted time and missed opportunities for effective treatment. Not only does research suggest that the use of NGS improves outcomes for patients,7 it may also be a powerful tool for improving health equity. Eliminating disparities in NGS testing could help to eliminate variations in care that can lead to poorer outcomes for patients in Black, Latinx, and other underserved communities.

At Genentech, support for comprehensive biomarker testing embodies a broader vision of delivering personalized treatment to every patient, said Dr. Fuchs. “We’re motivated by the big questions, like how all patients can benefit equally from medical innovation. That means our solutions have to be equally big, like making ‘know your biomarkers’ the norm for all patients, without exception.”

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1 American Cancer Society. Targeted Drug Therapy for Non-Small Cell Lung Cancer. Available online at: Accessed on October 28, 2021.
2 König D, Prince SS, Rothschild SI. Targeted therapy in advanced and metastatic non-small cell lung cancer. An update on treatment of the most important actionable oncogenic driver alterations. Cancers. 2021;13(4):1-52.
3 Barlesi F, Mazières J, Merlio JP, et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide program of the French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016;387(10026):1415-1426.
4 Bruno DS, et al. Racial disparities in biomarker testing and clinical trial enrollment in non-small cell lung cancer (NSCLC).ASCO 2021 Meeting Abstract. Available online at: Accessed on October 28, 2021.
5 RobertNJ, et al. Biomarker tissue journey among patients (pts) with untreated metastatic non-small cell lung cancer (mNSCLC) in the U.S. Oncology Network community practices.  ASCO 2021 Meeting Abstract. Available online at: Accessed on October 28, 2021.
6 Aisner DL and Riely GJ. Non–Small Cell Lung Cancer: Recommendations for Biomarker Testing and Treatment. JCCN. 2021;19(5.5).
7 Pennell NA, Mutebi A, Zhou Z-Y, et al. Economic impact of next-generation sequencing versus single-gene testing to detect genomic alterations in metastatic non–small-cell lung cancer using a decision analytic model. JCO Precis Oncol. 2019;3:1-9.