Articles on advances in immuno-oncology and non-small cell lung cancer were popular with readers in the past year.
The rise of immunotherapy and precision medicine in both non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC) is reflected in this year’s list of most-read articles in Evidence-Based Oncology™, the multistakeholder publication of The American Journal of Managed Care®. Disease states that have historically been the top causes of cancer death have seen progress in recent years, but 2021 brought some controversy.
5. After PD-1 Inhibitor Indications Are Withdrawn in SCLC, What Now?
One of the biggest regulatory stories of the year in oncology was the tale of the “dangling approval.” FDA’s reliance on accelerated approvals to bring potential life-saving therapies to patients based on early evidence meant that those approvals might be withdrawn if phase 3 trials failed to confirm the results. This was the year that came to pass. FDA held a series of hearings in late April that to weigh whether the fate of certain indications in SCLC. But as Martin J. Edelman, MD, of Fox Chase Cancer Center in Philadelphia, Pennsylvania, explained in this interview that appeared in our June issue, the decisions aren’t so cut and dry.
4. Possible Treatment Identified for Aggressive NSCLC Subset
This article from our February issue highlighted research from the Children’s Medical Center Research Institute at the University of Texas Southwestern, where Ralph DeBerardinis, MD, PhD, and fellow investigators discovered a potential treatment for patients with NSCLC who have KRAS and LKB1 mutations. Tumors with both mutations, known as KL tumors, are highly aggressive, and patients who have them usually do not respond to immunotherapy.
3. Real-World Evidence Is Key to Accelerating Oncology Approvals
In our June issue, contributor Jennifer B. Christian, PharmD, MPH, PhD, of IQVIA, discussed another emerging issue in oncology—the importance of real-world evidence (RWE) in drug approvals. As Christian writes, as therapeutic advances address more molecular subtypes, the traditional randomized clinical trial is not always possible due to challenges with patient accrual. RWE can complement a single-arm trial as a comparator arm to speed approvals and hold down trial costs. Christian discusses some early successes in the use of RWE. Later in the year, a presidential symposium held during the 2021 American Society of Hematology meeting addressed the need for international standards for RWE.
2. FDA Grants Tiragolumab Breakthrough Therapy Designation for PD-L1 High NSCLC
Another update from our February issue discussed tiragolumab, Genentech’s novel anti-TIGIT immunotherapy that is used in combination with atezolizumab (Tecentriq) in the first-line treatment of metastatic NSCLC patients whose tumors have high levels of programmed-death ligand-1 (PD-L1) and do not have EGFR or anaplastic lymphoma kinase mutations. Tiragolumab, the first anti-TIGIT therapy to be granted this designation, was featured during at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program. TIGIT is an immune checkpoint protein that is expressed on multiple immune cells, including T cells. More encouraging follow-up results were presented in early December 2021.
1. FDA Approves Tagrisso for Adjuvant Treatment of Early Stage EGFR Mutated NSCLC
This approval for osimertinib (Tagrisso) reported in our February issue marked the first FDA approval of an adjuvant treatment for NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. The approval was based on results from the phase 3 ADAURA trial, in which osimertinib showed significant improvement in disease-free survival (DFS) in patients with stage II to IIIA NSCLC with EGFRm tumors and in the overall trial population of stage IB to IIIA EGFRm NSCLSC. Results were presented at ASCO in May 2020. The review was conducted under the FDA Oncology Center of Excellence’s Project Orbis, which allows concurrent submission and review of oncology drugs among international partners.