PharmaShots Interview: Kathy Davy, VP of Oncology at Thermo Fisher Scientific Shares Insights on the Real-World Data from Patients with NSCLC at ASCO 2022

Shots:

Kathy spoke about the major outcomes from the real-world evidence data presented at the ASCO 2022
Kathy also emphasized on how next-generation sequencing can improve genomic testing
The interview gives a view of Thermo Fisher’s vision to bring targeted sequencing that provides faster results for clinicians

Smriti: Tell us in detail about the key findings from the real-world evidence study?

Kathy: Looking at real-world data from 525 patients in community hospitals across the U.S., researchers found treatment outcomes were significantly compromised in patients who started treatment (chemotherapy, immune checkpoint inhibitor, or both) before their molecular testing results were reported. Extrapolating these findings to the broader treatment landscape for patients with stage 4 non-small cell lung cancer (NSCLC), researchers from Integra Connect and Thermo Fisher concluded that universal genetic testing in stage 4 NSCLC is a critical first step in determining the best course of treatment for patients and thereby improving outcomes, including survival rates.

Of the 141 patients treated with chemotherapy (C), immune checkpoint inhibitor (ICI) or both before the availability of their actionable oncogenic drivers (AOD) results:

51 patients, who subsequently switched to tyrosine kinase inhibitors (TKIs) within 35 days, demonstrated a median apparent survival (AS) of 672 days (day range of 433-1010; HR, 1.719; p-value=0.0090).
90 patients who did not switch demonstrated a median AS of 435 days (day range of 350-560; HR, 2.360; p-value=<.0001).

In the control group of 384 patients who initiated treatment after receiving their AOD results, survival extended beyond the cutoff date in more than half of the patients. Therefore, a median AS could not be reached.

Smriti: How did molecular testing improve the treatment to improve patient outcomes?

Kathy: This study demonstrates not only the importance of having actionable genomic insights available to inform care decisions but also the real impact that speed to results has on patient outcomes. Results in the control group emphasize the need for near-universal non-squamous testing (as well as squamous never-smokers or age < 40) to inform decision-making as patients who harbor mutations but are never tested, or tested and received results after treatment initiation, may have significantly worse outcomes.

By having genomic results available as treatment decisions are made, patients who are eligible can be put on a targeted therapy that aligns with their specific tumor’s molecular makeup. This can save them months of unnecessary treatment, including chemo and immunotherapy, and can often yield a better outcome for the patient while reducing the risk of severe side effects. Validating this correlation through real-world patient data reaffirms the need to bring genomic testing closer to patients for faster results and reinforces our commitment to expanding the benefits of precision medicine.

Smriti: Tell us how the universal genetic testing in NSCLC 4 is important in the treatment procedure of NSCLC 4

Kathy: Our research with Integra Connect shows that universal molecular testing through rapid next-generation sequencing offers hope for these patients by connecting them with the best course of treatment to improve patient outcomes. Ultra-fast next-generation sequencing (NGS) for oncogenic driver detection to minimize turnaround time should be employed to avoid uninformed treatment decisions.

While the findings are promising, not all patients have access to molecular testing. Even for those with access, often samples are sent out of the treating institution, and the results are often delayed for weeks. This leads oncologists to make treatment decisions without the proper molecular information. Having NGS available onsite in community hospitals where patients are treated and ensuring results are rapidly available to care teams can change today’s cancer treatment paradigm by delivering actionable genomic insights in as little as a day.

Smriti: What other alternatives have the patients taken who are not able to access molecular testing?

Kathy: In this study, patients who did not have access to molecular testing or did not receive testing results in time to inform care were put on chemotherapy, immunotherapy, or a combination of both. This is problematic in that the NCCN and ASCO recommend that immunotherapy (IO) should not be initiated in patients with certain mutations in actionable biomarkers (e.g. EGFR) as sequential IO followed by tyrosine kinase inhibitors (TKI) treatment could be harmful in these patients with stage 4 metastatic NSCLC.

Despite this guidance, this study found that immunotherapy treatment was initiated either alone or in combination with chemotherapy – even in patients with an oncogenic driver as their molecular testing results weren’t used to inform this decision. Most often, this was because testing results were simply not yet ready at the time of the treatment decision.

Smriti: Based on Integra’s research, can you please describe how next-generation sequencing can improve genomic testing?

Kathy: The study’s findings open the door for a critical discussion on cancer care: the data shows having genomic test results available quickly improves patient survival rates, but not all patients have access to molecular testing. Even when patients are tested, often they’re started on non-targeted therapy while they wait weeks for outsourced results. We participated in this research with Integra Connect to crystallize our understanding of the importance of early test results based on real patient data.

Many oncologists and pathologists don’t realize that it’s possible to provide genomic test results for multiple biomarkers in just days. Community hospitals, where the majority of cancer patients are treated, often rely on outsourced testing or sequential, single-gene testing – both of which significantly slow the time to results. Thermo Fisher has simplified genomic testing so any hospital can bring it in-house. Our Genexus System is the first automated next-generation sequencing platform that can deliver results in as little as a single day, allowing researchers to assess multiple actionable markers with small sample requirements that can deliver results from more patients’ tissue or blood samples. Rapid NGS can help guide multiple treatment options and provides clear reports to help accelerate the pace of research and make fast, informed treatment decisions.

The data undeniably supports what our clinical partners have told us: having genomic test results early directly impacts patient outcomes. NGS specifically offers value by allowing clinical teams to simultaneously test for multiple actionable biomarkers with a single test. When available right away at hospitals everywhere, genomic testing will unlock a universe of targeted therapies for cancer patients.

Smriti: What are your upcoming plans in the field of NSCLC?

Kathy: Patients with stage 4 NSCLC have such a poor life expectancy that surgery, in general, is not recommended, and around a quarter of patients have a survival rate of fewer than three months after initial diagnosis. In the face of these odds, targeted therapies may be one of the few options available for patients with stage 4 NSCLC. The findings presented at ASCO are an important reminder that more work needs to be done to ensure patients get the full benefits of targeted therapies by ensuring molecular results are available early.

Our vision is for patients in all clinical settings to have access to timely molecular test results that can guide better therapy selection and improved health outcomes. When genomic testing is available on site, clinicians and patients have resulted in days instead of weeks so patients can start on the right therapy right away.

As the majority of newly diagnosed non-small cell lung cancer cases have already progressed to stage 4, immediate and effective treatment is needed. To marry this need for urgent action with the opportunity for precision oncology treatments, we are actively working to provide researchers, community hospitals, and oncology practices with access to user-friendly genomic tests that require minimal training and hands-on time.

Source: Canva

About the Author:

Kathy Davy is Vice President of Oncology Business Unit, Clinical Sequencing at Thermo Fisher Scientific. She completed her BS in Biology from the University of California, Irvine and MBA from The Fuqua School of Business is the business school of Duke University, North Carolina