Successful treatment with tislelizumab plus chemotherapy for SMARCA4-deficient undifferentiated tumor: a case report

Cancer Vaccines Are Showing Promise At Last

TOWARDS THE end of the 19th century William Coley, a surgeon in New York, made a surprising observation. One of his patients, close to death with a neck tumour, recovered after catching a serious bacterial skin infection. Intrigued, Coley tried to replicate the finding, injecting patients with a cocktail of killed bacteria to get their cancers to regress. He ended up treating over a thousand patients in this way, often successfully.

Top 5 NSCLC Content For 2024

Our top content for the year highlight many challenges the field of non–small cell lung cancer (NSCLC) encountered, with data showing both setbacks in clinical trial results and advancements in screening recommendations for at-risk patients.

Throughout 2024, developments in non–small cell lung cancer (NSCLC) highlighted both progress and challenges in treatment and screening. Sacituzumab govitecan failed to improve overall survival (OS), and a biologics license application (BLA) for datopotamab deruxtecan was withdrawn following initial promising results. Experts also emphasized the need for comprehensive genomic profiling (CGP) to address testing gaps, and updated guidelines expanded lung cancer screening eligibility by removing quit time and reducing pack-year criteria.

Please also visit our dedicated NSCLC page for exclusive content from the space.

5. Sacituzumab Govitecan Monotherapy for NSCLC Disappoints in EVOKE-01 Trial Update

In this article from January, data showed that sacituzumab govitecan-hziy (Trodelvy; Gilead) disappointed investigators in the phase 3 EVOKE-01 trial (NCT05089734), in that the TROP-2–directed antibody drug conjugate (ADC) did not improve OS, the study's primary end point for patients. Gilead announced at the time that although patients who did not have a response to their previous anti–PD-L1 treatment did see a 3-month OS improvement, these results also were not seen among patients who had responded to their previous anti–PD-L1. The good news, however, was that no new safety signals for sacituzumab govitecan were identified and the treatment was well tolerated.

Read this article.

4. Experts Sound the Alarm on Lack of Comprehensive Genomic Profiling in NSCLC

Labcorp data from single-gene testing (SGT) were used to contact and offer oncologists CGP, based on previous research showing extreme variation in molecular testing patterns for NSCLC, investigators said. Eighty community practices, accounting for 561 patients with advanced or metastatic disease, were represented, with 27% of these patients having a negative result from SGT within 6 months of their CGP. Results showed that geographic region, turnaround time, and tissue type and age were associated with variation in CGP order strategy.

Read this article.

Throughout 2024, developments in the field of non–small cell lung cancer highlighted both progress and challenges in treatment and screening.Image Credit: © mi_viri-stock.Adobe.Com

3. FDA Accepts BLA for Datopotamab Deruxtecan for Nonsquamous NSCLC

In February, Daiichi Sankyo and AstraZeneca submitted their BLA for the ADC, backing it with data from the phase 3 TROPION-Lung01 trial (NCT04656652). These data showed a statistically significant improvement in progression-free survival with the monoclonal antibody/chemotherapy combo vs docetaxel for previously treated adults with locally advanced or metastatic nonsquamous NSCLC. However, in November, Daiichi Sankyo and AstraZeneca withdrew this application, replacing it with a new BLA for accelerated approval based on data from the phase 2 TROPION-Lung05 trial (NCT04484142) and supported by data from TROPION-Lung01 and the phase 1 TROPION-PanTumor01 trial (NCT03401385).

Read this article.

2. Updated Guidelines Expand Lung Cancer Screening Eligibility for At-Risk Patients: Dr Melinda Aldrich

November 2023 updates to lung screening guidelines from the American Cancer Society were at the center of this January 2024 interview with Melinda C. Aldrich, PhD, MPH, associate professor in the departments of Medicine, Thoracic Surgery, and Biomedical Informatics at Vanderbilt University. With 10 years having passed since the previous guidelines' update, this update removed a longstanding screening eligibility criterion, quit time, potentially expanding the pool of patients eligible for a lung cancer screen. It also showed alignment with the US Preventive Services Task Force, in that the revised down another screening criterion, pack-years, from 30 to 20.

Read this interview.

1. Biomarker Testing: Key to Personalized Lung Cancer Care

In part 1 of our August 3-part interview with David P. Carbone, MD, PhD, director of the thoracic oncology center at The Ohio State University in Columbus, he discussed the importance of biomarker testing in NSCLC. Especially deserving of attention is the treatment transformation the lung cancer space has seen from biomarker testing, which now permits therapies to be tailed to the patient and their cancer. Patients with both early- and late-stage disease can benefit from this panel testing, which is important overall, but should be performed prior to therapy initiation, Carbone explains.

Watch this interview.

Datopotamab Deruxtecan By Daiichi Sankyo For Squamous Non-Small Cell Lung Cancer: Likelihood Of Approval

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Datopotamab deruxtecan overview

DS-1062 is under development for the treatment of advanced solid tumors including metastatic hormone refractory (castration resistant, androgen-Independent) prostate cancer, cervical cancer, peritoneal cancer, fallopian tube cancer, epithelial ovarian cancer, metastatic ovarian cancer, metastatic biliary tract cancer; bladder cancer, squamous and non-squamous NSCLC, metastatic colorectal cancer, transitional cell carcinoma, metastatic transitional (urothelial) tract cancer, transitional cell cancer (urothelial cell cancer, biliary tract cancer, transitional cell cancer (urothelial cell cancer, head and neck cancer squamous cell carcinoma, esophageal cancer, metastatic adenocarcinoma of the pancreas, endometrial cancer, small-cell lung cancer, HR+, HER2- breast cancer, HER2 positive breast cancer, metastatic triple negative breast cancer, non muscle invasive bladder cancer and, lung adenocarcinoma, non small cell lung cancer. It is administered through intravenous route as a solution. The drug candidate is a TROP2-directed ADC consisting of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to a highly potent topoisomerase l inhibitor payload. It targets Trop 2 protein. The therapeutic candidate is being developed based on antibody drug conjugate (ADC) DXd-ADC platform technology.

It was also under development for the treatment of pancreatic cancer.

Daiichi Sankyo overview

Daiichi Sankyo is a global healthcare company that focuses on the discovery, development, and delivery of innovative medical solutions. The company offers a wide range of prescription drugs, over the counter (OTC) drugs, vaccines, and others. Its portfolio encompasses medicines for cardiovascular, neurological, nephrological, diabetic, metabolic, and infectious diseases, and various types of cancers. Besides cancer, the company's other research areas include rare diseases and immune disorders. Daiichi Sankyo sells its products through its group companies and an extensive network of medical representatives. It has operations in North America, South and Central America, Europe, and Asia. Daiichi Sankyo is headquartered in Tokyo, Japan.

For a complete picture of Datopotamab deruxtecan's drug-specific PTSR and LoA scores, buy the report here.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData's Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData's Pharmaceutical Intelligence Center.

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