Aptamer Detection of Mycobaterium tuberculosis Mannose-Capped Lipoarabinomannan in Lesion Tissues for Tuberculosis Diagnosis
Tagrisso May Improve Survival In Advanced EGFR-Mutant NSCLC
Tagrisso is associated with positive outcomes among patients with unresectable stage 3 EGFR-mutant non-small cell lung cancer.
For patients with unresectable stage 3 EGFR-mutant non-small cell lung cancer, Tagrisso associated with positive outcomes.
Tagrisso (osimertinib) has been found to be associated with positive outcomes, including improvements in overall survival, among patients with unresectable stage 3 EGFR-mutant non-small cell lung cancer (NSCLC).
These findings, it has been posited, position Tagrisso as the new standard of care treatment for this patient population, according to findings from the international phase 3 LAURA study presented at the European Lung Cancer Congress (ELCC) 2025.
"In summary, this updated overall survival analysis from the LAURA study demonstrates an improved favorable trend for overall survival benefit with [Tagrisso] over placebo," stated Dr. Suresh S. Ramalingam in his presentation of the data at the ELCC meeting. "This was seen despite the high proportion of patients in the placebo group that went on to receive another third generation [tyrosine kinase inhibitor], specifically [Tagrisso], nearly 80%."
"And we also showed that there are clinically meaningful improvements for [Tagrisso] over placebo in time to first subsequent therapy, progression-free survival 2 and time to second subsequent therapy. … In conclusion, these data further substantiate the fact that [Tagrisso] after definitive chemo radiotherapy is the new standard of care for patients with locally advanced non-small cell lung cancer bearing an EGFR exon 19 or 21 mutation."
Ramalingam is the executive director of the Winship Cancer Institute of Emory University as well as an associate vice president for cancer of Woodruff Health Sciences Center, both in Atlanta.
Results from the LAURA trial supported the U.S. Food and Drug Administration's September 2024 approval of Tagrisso for adults with locally advanced, unresectable stage 3 NSCLC whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. The trial was held at more than 145 centers in more than 15 counties including the United States as well as in Europe, South America and Asia, according to a news release issued by AstraZeneca, the manufacturer of Tagrisso.
Updated results from the trial presented at the recent ELCC meeting showed an improvement in overall survival among patients treated with Tagrisso versus placebo, with median overall survival times of 58.8 months and 54 months, respectively. Notably, 78% of patients on placebo received subsequent treatment with Tagrisso after experiencing disease progression, according to the news release.
In the trial, patients underwent chemoradiotherapy and then, if their disease had not progressed within six weeks, they were randomized to treatment with Tagrisso (143 patients) or to receive placebo (73 patients).
With a Nov. 29, 2024 data cut-off date, the updated overall survival analysis was based on 66 events, with a median overall survival follow-up of 39.4 months in the Tagrisso arm and 35.2 months in the placebo arm.
Of the 143 patients in the Tagrisso group, 48% remained on study treatment, 38% began a first subsequent therapy and 14% received no subsequent treatment. For patients in the placebo group, those respective rates were 5%, 82% and 12%.
The median time to first subsequent treatment was 43.8 months in the Tagrisso arm and 9.5 months in the placebo arm, while median progression-free survival 2 times were 48.2 months and 47.4 months, respectively. Additionally, the median time to second subsequent therapy was not reached in the Tagrisso arm and 47.4 months in the placebo arm.
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'It Can Save Their Lives': Annual Lung Cancer Screening Improves Cancer Detection Rate
March 24, 2025
3 min read
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Key takeaways:Annual lung cancer screening, or LCS, detects cancer at a higher rate and at earlier stages, findings suggest.
According to Roger Y. Kim, MD, MSCE, DAABIP, ATSF, an assistant professor of medicine at the Hospital of the University of Pennsylvania, LCS with low-dose CT "has not been as effectively publicized or implemented in the United States as other cancers [have], such as colorectal, breast or prostate cancer.
"Adherence to annual LCS has been suggested as a quality metric for screening programs because in large randomized clinical trials, most lung cancers were diagnosed during follow-up rounds of screening," he told Healio. "However, previously there was no concrete real-world data that linked adherence across multiple rounds of screening to improved early-stage lung cancer detection rates."
In the retrospective cohort study, Kim and colleagues examined data from 10,170 adults aged 55 to 75 years who had undergone an initial LCS between Jan. 1, 2015, and Dec. 31, 2018, in one of five health care systems.
LCS adherence among people who received positive results at the initial screening (T0) was defined as a chest CT conducted between 10 to 18 months (T1) and 22 and 30 months (T2) after the baseline LCS.
T1 and T2 screening adherence for people with negative results at T0 were defined as a chest CT conducted between 11 and 21 months and 28 and 36 months after the initial screening, respectively.
Adherence waned but still helped detectionThe researchers found that LCS adherence dropped from 61.2% (95% CI, 60.2%-62.2%) at year 1 to 50.5% (95% CI, 49.5%-51.4%) at year 2.
Overall, 2.7% (95% CI, 2.4%-3.1%) of patients were diagnosed with lung cancer during the 36 months of follow-up, with a higher proportion diagnosed among those with positive vs. Negative LCS results at baseline (12.1% vs. 1%).
The researchers reported that the rate of incident lung cancer diagnosis was:
The rates of lung cancer diagnosis were higher among people who adhered to LCS compared with those who did not during rounds T1 (1% vs. 0.2%) and T2 (1.3% vs. 0.2%).
Meanwhile, a larger proportion of early-stage lung cancers were diagnosed during round T2 among people adherent to T2 screening vs. Those who were not (73% vs. 25%).
Kim and colleagues noted that the associations between LCS adherence and lung cancer diagnosis remained during rounds T1 (adjusted RR = 4.64; 95% CI, 2.57-8.37) and T2 (adjusted RR = 5.9; 95% CI, 3.34-10.43) in multivariable analyses, but T1 adherence was not tied to lung cancer diagnosis during round T2.
Tracking adherence of 'critical importance'Kim noted that the findings "emphasize the critical importance of measuring and tracking longitudinal adherence to annual LCS."
"It is clear that getting high-risk patients enrolled in a screening program is no longer enough," he said to Healio. "Programs must additionally allocate sufficient resources to ensuring that patients come back for their annual screens in order to fully realize the potential benefits that lung cancer screening can provide to promote early detection of lung cancer and, ultimately, reduce lung cancer mortality."
He highlighted the fact that one in 16 Americans will be diagnosed with lung cancer in their lifetime, "and nearly everyone in the country personally knows someone impacted by lung cancer.
"The public needs to understand the importance of LCS and make sure that they or their loved ones who are eligible for screening get screened," Kim added. "It really can save their lives."
For more information:Roger Y. Kim, MD, MSCE, DAABIP, ATSF, can be reached at roger.Kim@pennmedicine.Upenn.Edu.
Sources/DisclosuresCollapse Disclosures: Kim reports receiving grants from American Cancer Society, National Cancer Institute, Respiratory Health Association and University of Pennsylvania's McCabe Fund. Please see the study for all other authors' relevant financial disclosures.Add topic to email alerts
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Global Submission Seeks Approval For Sugemalimab Treatment In NSCLC
An application was submitted to the European Medicines Agency seeking approval for treatment with sugemalimab in stage 3 NSCLC following chemoradiotherapy.
Global submission seeks approval for sugemalimab treatment in stage 3 non-small cell lung cancer after chemoradiotherapy, supported by phase 3 GEMSTONE-301 study results.
A Type 2 variation application has been submitted to the European Medicines Agency seeking approval for treatment with sugemalimab in patients with unresectable stage 3 non-small cell lung cancer (NSCLC) who have not progressed following concurrent or sequential platinum-based chemoradiotherapy, according to a press release from CStone Pharmaceuticals.
The application is supported by data from the phase 3 GEMSTONE-301 study, a multicenter, randomized, double-blind study. The investigation is evaluating treatment with sugemalimab as consolidation therapy in patients with unresectable stage 3 NSCLC post-chemoradiotherapy.
According to results from the study, which were published in The Lancet Oncology, sugemalimab had a 36% reduction in risk of disease progression or death, significantly improved progression-free survival. Moreover, when utilized in this patient population, sugemalimab led to a 56% reduction in risk of death, with a strong positive trend toward overall survival benefit. There was a consistent clinical benefits across subgroups, regardless of prior chemoradiotherapy modality (concurrent or sequential), as well as a favorable safety profile, no new safety signals identified.
"Following sugemalimab's approval in Europe for stage 4 NSCLC, we are working closely with the European Medicine's Agency to expand its indications in earlier stage lung cancer and other malignancies" Dr. Jason Yang, chief executive officer and president of R&D, as well as executive director at CStone, stated in the press release. "With its demonstrated outstanding efficacy and safety profile, sugemalimab is poised to address critical unmet needs for [patients with] stage 3 NSCLC. We remain steadfast in expanding global access through strategic partnerships and collaborations with regulatory authorities, ensuring this innovative therapy reaches patients worldwide."
This is the second regulatory submission for sugemalimab to the European Medicines Agency, according to the release, following its initial European approval in 2024 for metastatic squamous and non-squamous NSCLC. If granted, this new indication would help fill a treatment gap in stage 3 NSCLC, where only one PD-L1 antibody is currently approved in Europe. By demonstrating efficacy in both stage 3 and 4 NSCLC, sugemalimab has the potential to become a foundational immunotherapy option for lung cancer treatment, the release states.
Sugemalimab is an anti-PD-L1 monoclonal antibody and is a fully human, full-length immunoglobulin G4 monoclonal antibody. The agent was developed CStone by utilizing the OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step, according to the news release. The agent, due to its mechanism of action and makeup, may reduce the risk of immunogenicity and toxicity for patients. In turn, according to the release, this offers a unique advantage over similar drugs.
For the patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations, first-line treatment with sugemalimab has been approved by both the European Commission as well as the Medicines and Healthcare products Regulatory Agency in combination with platinum-based chemotherapy.
Additionally, sugemalimab is approved for five indications by The National Medical Products Administration of China.
These approvals include sugemalimab plus chemotherapy in the first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC; the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy; for the treatment of patients with relapsed or refractory extranodal T-cell lymphoma; sugemalimab in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; and sugemalimab in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with a PD-L1 expression combined positive score of 5 or greater.
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