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Clinical

Bill 1196 / Assembly Bill 1673 aims to improve access to precision medicine for patients with cancer in New York by requiring all state-regulated health plans to cover biomarker testing when it is supported by medical and scientific evidence.

Oncologists Back Legislation to Help Improve Access to Biomarker Testing

In an interview with Targeted Oncology, John Diaz, MD summarized the ovarian cancer treatment paradigm, and discussed the role of genomic testing and novel targets being explored in the space.

New Therapies Offer More Precision Treatment for Ovarian Cancer

As we identify more targets...there will probably be more and newer, perhaps even better, therapeutics than we have currently, said Dennis J. Slamon, MD.

A Decade of Breast Cancer at the Molecular Level: Pioneering Personalized Medicine

According to experts, routine biomarker testing has become a standard part of care for several common tumor types. 

From Then to Now: How Genomic Testing for Cancer Has Expanded

Specific biliary tract cancer clusters have distinct clinical and biologic features which may provide opportunities for therapeutic development.

Subtype-Specific Immune Signatures Found in BTC Profiling Data

Lori J. Wirth, MD, associate professor of medicine at Harvard Medical School and medical director of the Center for Head and Neck Cancers at Massachusetts General Hospital, discusses a new assay with the ability to perform DNA and RNA sequencing.

When it comes to next-generation sequencing, DNA sequencing alone is not a good testing method for identified fusions in patients with cancer. According to Wirth, in addition to mutation, insertions, and deletions, fusions are important biomarkers. This fact was demonstrated through a real-world study for which data were presented at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.

The study utilized the Tempus assay which has the ability to perform both DNA and RNA sequencing, explains Wirth.

 One thing that I think is important to highlight as well related to data from ASCO and NTRK is 1 report. That was an analysis of a real-world experience with Tempus in genotyping tumors in order to identify mutations, insertions, deletions, and fusions. Fusions in this setting are so important. And we have to remember, fusions can be difficult to detect, particularly with DNA sequencing. And the Tempus assay, it incorporates both DNA sequencing as well as RNA sequencing in order for it to complete the biomarker testing for patients with advanced cancer who need treatment.

 And this real-world analysis did show that DNA sequencing alone isn't all that great at detecting fusions RNA sequencing alone is better, but you put the 2 together. And that's where you get the highest detection rate of these oncogenic kinase fusions that are becoming more and more targetable in oncology. So, I think that that biomarker testing issue remains a very important aspect of the forefront of this new precision oncology drugs.

Videos

Lori J. Wirth, MD, discusses a new assay with the ability to perform DNA and RNA sequencing to better detect gene fusions. 

Novel Approach to Next-Generation Sequencing of NTRK Tumors

Michael J. Overman, MD, professor at The University of Texas MD Anderson Cancer Center, and committee vice chair at The University of Texas MD Anderson Cancer Center – ECMS in Houston, Texas, discusses the advances in testing for rare genomic alterations in colorectal cancer (CRC).

Historically, experts in the field focused on 

 status, and anti-EGFR therapies, Overman explained. Over the years, mindsets have expanded to also consider alterations like 

, HER2, and prognostic factors like mismatch repair deficiency. Many of these are now mandated for testing in CRC, Overman says.

There are also rare genomic alterations that fall under the gene fusion category that have available treatment options and should be considered for testing, according to Overman.

Michael J. Overman, MD, discusses the advances in testing for rare genomic alterations in colorectal cancer.

Conference News

Testing for Rare Genomic Alterations in Colorectal Cancer

Jennifer Marie Suga, MD, a medical oncologist at Kaiser Permanente Vallejo Medical Center, discusses how the results from next-generation sequencing (NGS) tests are assessed to help physicians manage their patients in real-time.

Suga says that the genomic oncology committee evaluated each of those results for several things. They looked at whether there is an FDA-approved drug for that patient based on their NGS results. Another aspect they considered was if an FDA-approved drug for an alternative cancer had clinical evidence of activity in that patient’s cancer setting. The committee made decisions based on whether there was a relevant clinical trial within the patient’s network or in the patient’s local area. They also looked at whether the patient required additional genetic testing and counseling as determined by their genetics team.

A comprehensive review showed that approximately 40% of patients had an actionable mutation in NGS findings. Among those patients, certain tumor types such as lung cancer and breast cancer have about a 50% rate of actionable mutations. About 22% of those patients were potentially eligible for a clinical trial within the area, and about 11% were eligible for an FDA-approved drug or 1 that was promising in that indication, according to Suga.

<< View more resources and information regarding genomic testing

Jennifer Marie Suga, MD, discusses how the results from next-generation sequencing tests are assessed to help physicians manage their patients in real-time.

Committee Helps Physician's Find Best Options for Patients Through NGS

Jennifer Marie Suga, MD, a medical oncologist at Kaiser Permanente Vallejo Medical Center, discusses implementing a genomic oncology program at Kaiser Permanente Northern California through large-scale genomic next generation sequencing (NGS) testing of patients with advanced cancers in the community setting.

Suga says that the goals of this project are to address how to increase the utilization of NGS testing and make it more widespread in community oncology practices. One of the practical challenges for testing in the community setting is lack of access at scale; many health care systems and institutions do not have a lot of robust infrastructure and processes to deliver routine broad-spectrum NGS testing for all patients with advanced cancer, according to Suga.

Employing this comprehensive genomic oncology program will hopefully support community oncologists from the time they ordered the test up to when they receive the results to ultimately increase the utilization of NGS in the community setting, Suga explains. To implement this program, Kaiser Permanente partnered with Strata Oncology, who provided a form through their clinical trials protocol for Kaiser to provide the NGS test for community practices. After that, they will work toward implementing a process for ordering the test all the way through interpretation and results.

<< View more of Targeted Oncology's coverage from the 2020 ASCO Virtual Annual Meeting

Jennifer Marie Suga, MD, discusses implementing a genomic oncology program at Kaiser Permanente Northern California through large-scale genomic next generation sequencing testing of patients with advanced cancers in the community setting.

Discussing How to Bring Next-Generation Sequencing to Community Practices

Julie R. Brahmer, MD, co-director of the Upper Aerodigestive Department in the Bloomberg-Kimmel Institute for Cancer Immunotherapy, director of Thoracic Oncology, and professor of oncology, Johns Hopkins Medicine, discusses the role of molecular testing for patients with lung cancer and why this is particularly important for those with early-stage disease.

Guidelines recommend that all patients with nonsmall cell lung cancer undergo molecular testing at the time of diagnosis, Brahmer says. This is especially important in patients with advanced disease, though. For patients with early-stage disease, physicians are not routinely using driver mutations or standard therapy, adjuvant chemotherapy. These patients also should still receive molecular testing upon diagnosis.

There are many clinical trials ongoing, so checking for mutations, fusions, and other alterations may help determine which patients should be placed in a study. For example, Brahmer says patients with EGFR or ALK fusions in their tumors could be placed in the ALCHEMIST trial or others that are happening in the adjuvant setting.

For patients with advanced disease, all patients should receive molecular testing to determine the presence of driver mutations or fusions that may change their prognosis and direct physicians to a specific targeted therapy, Brahmer concludes.

<< View more resources and information regarding lung cancer

Julie R. Brahmer, MD, discusses the role of molecular testing for patients with lung cancer and why this is particularly important for those with early-stage disease.

Molecular Testing Recommendations for NSCLC

Willemina R. Geurts-Giele, PhD, University Medical Center, Rotterdam, The Netherlands, discusses 2 approaches used to detect the

exon 14 skipping mutation in patients with non-small cell lung cancer (NSCLC).

Clinicians can use either RNA or DNA, Geurts-Giele says. With RNA, a simple polymerase chain reaction is used because it is the same event, which is very easy. However, the downside is that patients with NSCLC do not have as much material.

DNA analyses are routinely done in pathology departments, while the use of RNA is still evolving in labs. In her analysis, Guerts-Giele used DNA analysis to determine the

exon 14 skipping mutation because they regularly run the analysis on their patient&rsquo;s materials.

Willemina R. Geurts-Giele, PhD, discusses 2 approaches used to detect the MET exon 14 skipping mutation in patients with non-small cell lung cancer.

Detecting the MET Exon 14 Skipping Mutations in NSCLC

James L. Mohler, MD, associate director and senior vice president for translational research, and professor of oncology, Roswell Park Comprehensive Cancer Center, discusses the evolving role of genetic testing in patients with prostate cancer following the updates to the National Cancer Care Network (NCCN) Guidelines, which now include guidance for better practice in terms of conducting genetic testing in this patient population.

The importance of genetic testing has been recognized, says Mohler, but there is a deficient in the number of highly trained and qualified genetic counselors. Although physicians are functioning well despite these odds, certificate programs are available that provide more individuals with short courses to improve on their knowledge of genetic testing so that physicians can do a better job at pre-genetic testing counseling.

As a urologist, Mohler says that he lacks in this area of expertise as well, which is why more genetic counselors need to be trained.

James L. Mohler, MD, discusses the evolving role of genetic testing in patients with prostate cancer following the updates to the National Cancer Care Network Guidelines, which now include guidance for better practice in terms of conducting genetic testing in this patient population.

Expert Discusses Evolving Role of Genetic Testing in Prostate Cancer

Kevin Halling, MD, PhD, a consultant in the Division of Laboratory Genetics and Genomics and Department of Laboratory Medicine and Pathology at the Mayo Clinic, discussed the clinical utility of RNA-sequencing methods in patients with cancer at the 2019 Association for Molecular Pathology (AMP) Annual Meeting and Expo. Halling says RNA sequencing is a very powerful diagnostic technique.

According to Halling, these methods can be used to detect not only gene fusions in patients with cancer, but RNA sequencing can also detect point mutations and small indels. Additionally, pathologists can use RNA sequencing techniques to measure gene expression in the patient&rsquo;s tumors.

Kevin Halling, MD, PhD, discussed the clinical utility of RNA-sequencing methods in patients with cancer at the 2019 Association for Molecular Pathology Annual Meeting and Expo. Halling says RNA sequencing is a very powerful diagnostic technique.

Expert Highlights the Clinical Utility of RNA Sequencing Methods in Cancer

Leonard G. Gomella, MD, professor, chair, Department of Urology, and director, Sidney Kimmel Cancer Center Network, Thomas Jefferson University Hospital, discusses the factors that determine which patients with prostate cancer should undergo genetic testing.

The National Comprehensive Cancer Network (NCCN) guidelines state that any patient with multiple family members who are under the age of 55 with prostate cancer should consider getting genetic testing, says Gomella. Additionally, for patients with a heavy burden of other cancers, such as breast cancer, ovarian cancer, melanoma, or pancreatic cancer in the family, or those with hereditary cancer syndromes, they should also consider testing.

Gomella says the least controversial area in genetic testing currently is for the testing of men who present with metastatic prostate cancer as the disease could be inherited. PARP inhibitors, a new class of drugs, will soon be introduced to this space, a treatment that will be driven by genetic testing results.

Leonard G. Gomella, MD, discusses the factors that determine which patients with prostate cancer should undergo genetic testing.

Considering Genetic Testing in Patients With Prostate Cancer

Matthew P. Goetz, MD, consultant, Division of Medical Oncology, Department of Oncology, Mayo Clinic, discusses how genomic assays can help identify patients with estrogen receptor (ER)positive breast cancer who will benefit from the addition of chemotherapy to endocrine therapy.

There are a number of considerations when selecting a genomic assay for these patients, says Goetz. For the past 10 to 15 years, the focus has been on identifying patients with ER-positive disease who could do well with endocrine therapy alone versus those who need the addition of chemotherapy to treatment. A number of genomic assays are now in development to help identify those patients that can be de-escalated from chemotherapy.

Over the last few years, a number of different clinical trials have helped in identifying which genomic assays are most useful in this setting, and recent data have confirmed the utility of these assays in patient selection. Data suggest that the most useful assay is the Oncotype DX test, which assigns patients a recurrence score.

Matthew P. Goetz, MD, discusses how genomic assays can help identify patients with ER&ndash;positive breast cancer who will benefit from the addition of chemotherapy to endocrine therapy.

Genomic Assays Impact Treatment Decisions in Patients With ER+ Breast Cancer

The PACIFIC trial has really changed the outlook for stage III patients. However, we still don&rsquo;t have 100% cure rate in this particular setting. I think some of the unmet needs are trying to get a better definition of who gets benefit from immunotherapy. Are there patients in which PD-1 or PD-L1 inhibition isn&rsquo;t enough? We have other checkpoint inhibitors, CTLA4 inhibitors.

Other targets are coming in clinical trials. How do you identify patients who may need either a different or more enhanced immunologic effect? How do we use targeted therapies in this population? I mentioned before about

mutations. What&rsquo;s the role of an EGFR TKI [tyrosine kinase inhibitor] in stage III disease? Those trials are ongoing. ALK-positive patients, ROS1-positive patients, and other subsets.

One of the challenges in studying these in stage III disease is that these are very uncommon to rare patients. We don&rsquo;t have a lot of them, so it&rsquo;s very difficult to study them. So I think that the unmet needs focus around how do we take everything we&rsquo;ve learned in stage IV disease where we are clearly improving survival and translating that to stage III disease integrating targeted therapy, identifying patients beyond the biomarker of PD-L1 who may get greater benefit, those sorts of things. So there&rsquo;s a lot of work to do. I think PACIFIC is a great kind of launching pad to get some kind of optimism and enthusiasm for studying these issues in stage III disease.

I think the practical advice for the practicing oncologist is the importance of accurate staging. So you identify patients with stage III disease. Most of the patients with stage III disease do have unresectable disease, so surgery doesn&rsquo;t play a role. I think for the practicing clinician, they need to embrace the PACIFIC data. They have the opportunity to provide a patient with a higher cure rate and better long-term survival, that concurrent chemoradiotherapy, doing it well in the multidisciplinary setting. The medical oncologist needs to be hand-in-hand with the radiation oncologist. We have to work together as a team. You have to get the patient through concurrent chemoradiotherapy without missing any major part of their radiation or their chemotherapy&hellip; You have to use durvalumab within 6 weeks of completing radiation. You should be with your radiation oncologist. As a medical oncologist, you should be making sure that you have a comprehensive plan to get the patient through with minimal esophagitis, with minimal fatigue, with minimal myelosuppression, so that that patient going through very tough therapy with chemoradiation is fit and can recover from that within a week or two and be able to start immunotherapy, certainly within 6 weeks. But I like to start it as early as I possibly can in these patients.

And there are some data from the PACIFIC trial suggesting that if you start it earlier, within 2 weeks, that there might be greater benefit. So all things being equal, I like to start it as quickly as possible. But part of the ability to do that is you make sure that you manage the expected toxicities of chemoradiation. The most important one is esophagitis, that you manage that prospectively and aggressively and try to minimize any high-grade toxicities with regard to the esophagus, and let patients recover quickly so they can move on to immunotherapy.

NSCLC Stage III Unmet Needs and Practical Advice

One of the questions that the PACIFIC trial raises is that if you have this clinically impressive and statistically significant survival advantage for the use of durvalumab after chemoradiotherapy in unresectable patients, would you expect the same benefit in patients who have resectable stage I, II, or III disease and have undergone surgery?

Those trials are ongoing. In my practice, I would not recommend it until we have some randomized data that [show] that there is an advantage to it. Again, I think we realize that patients who undergo surgery tend to be fit. The goal of surgery is to cure those patients. We know that adjuvant chemotherapy plays a role. I am cautiously optimistic that we may see positive data in this setting. It makes sense to me. But in terms of a routine clinical practice today, in the absence of randomized data from a phase III trial, I would personally not recommend the use of it in the surgical adjuvant setting. I would encourage clinicians to put patients on clinical trials that are evaluating this at this particular time.

You know we talked before about the issue of pneumonitis and oftentimes if you&rsquo;re doing CT scans on patients within 6 weeks of completing chemoradiation to prove that they don&rsquo;t have disease progression because you want to use durvalumab, in a fair number of patients, you are going to see changes on the CT scan that look like radiation pneumonitis. If the patient is asymptomatic, then that would be a kind of a grade 1 radiation pneumonitis. It&rsquo;s an expected finding at that particular time. If the patient is asymptomatic it would not deter me from recommending durvalumab in this setting. Again, I mentioned before that there was a slight increase of about 10% in grade 1 or 2 pneumonitis as a result of durvalumab but no increase in the rate of grade 3 or 4 pneumonitis as a result of using durvalumab versus placebo. So asymptomatic grade 1 pneumonitis would not deter me from using a checkpoint inhibitor in that setting.

GENOMIC TESTING

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