Boehringer’s lung cancer medicine Hernexeos is the second “national priority” voucher winner to gain a speedy approval. Elsewhere, a landmark gene therapy was withdrawn and a Pfizer deal paid dividends.

Original title: “Boehringer drug approved in 44 days; BioMarin shelves Roctavian”

increase in second primary lung cancers in a nation wide cohort study from sweden

Original title: “Increase in second primary lung cancers in a nation-wide cohort study from Sweden.”

D3S-001 has received FDA breakthrough therapy and orphan drug designations in KRAS G12C-mutated NSCLC and CRC, respectively. The FDA has granted breakthrough therapy designation to D3S-001 for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non–small cell lung cancer (NSCLC) who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.1 · D3S-001 has also been granted orphan drug designation (ODD) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC). D3 Bio, Inc. announces FDA breakthrough therapy designation and orphan drug designation for D3S-001 for the treatment of patients with KRAS G12C-mutated cancers. News Release. D3 Bio. August 28, 2025. Accessed August 28, 2025. D3S-001 received FDA breakthrough therapy and orphan drug designations for KRAS G12C-mutated NSCLC and CRC, highlighting its potential in addressing unmet needs. "We are very pleased to receive both breakthrough therapy and orphan drug designations from the FDA for D3S-001, which highlights D3S-001's promising potential to address critical unmet needs in patients with KRAS G12C–mutated cancers," George Chen, founder and CEO of D3 Bio, stated in the news release.1 "These designations also recognize D3S-001's novel profile as a next-generation KRAS G12C inhibitor.

Original title: “D3S-001 Receives FDA Breakthrough Therapy, Orphan Drug Designations in Select KRAS G12C-Mutant Solid Tumors | OncLive”

dsg2 cancer stem cells co located with fap myofibroblasts in the tumor boundary that determines the efficacy of immunotherapy in non small cell lung cancer

Original title: “DSG2+ Cancer Stem Cells Co-Located With FAP+ Myofibroblasts in the Tumor Boundary That Determines the Efficacy of Immunotherapy in Non-Small Cell Lung Cancer.”

exploring the effects of tinzaparin and cisplatin on lung cancer cells in vitro

Original title: “Exploring the effects of tinzaparin and cisplatin on lung cancer cells in vitro.”

In this randomized phase 3 trial, patients with treatment-naive stage III–IV nonsmall cell lung cancer who received sintilimab or pembrolizumab in combination with chemotherapy early in the day (before 15:00 h) experienced longer progression-free survival compared with those receiving late ... In this randomized phase 3 trial, patients with treatment-naive stage III–IV nonsmall cell lung cancer who received sintilimab or pembrolizumab in combination with chemotherapy early in the day (before 15:00 h) experienced longer progression-free survival compared with those receiving late time-of-day infusions. Retrospective studies suggest that early time-of-day (ToD) infusions of immunochemotherapy may improve efficacy. However, prospective randomized controlled trials are needed to validate it. In this randomized phase 3 LungTIME-C01 trial, 210 patients with treatment naive stage IIIC–IV nonsmall cell lung cancer (NSCLC) lacking driver mutations were randomly assigned in a 1:1 ratio to either an early or late ToD group, defined by the administration of the first four cycles of an anti-PD-1 agent before or after 15:00 h. The primary endpoint was progression-free survival (PFS), while secondary endpoints included overall survival (OS) and objective response rate (ORR). Nature Medicine - In this randomized phase 3 trial, patients with treatment-naive stage III–IV nonsmall cell lung cancer who received sintilimab or pembrolizumab in combination with... Extended Data Table 1 Information about the clinical trial ... Extended Data Table 4 Baseline demographics and disease characteristics of patients included in the flow cytometry analysis by study group

Original title: “Time-of-day immunochemotherapy in nonsmall cell lung cancer: a randomized phase 3 trial | Nature Medicine”

Sherlock-Lung study researchers use large-scale, multi-omics analysis to identify biomarker of aggressive lung tumors.

Original title: “NIH-led study reveals role of mobile DNA elements in lung cancer progression”

Forty percent of cancers diagnosed in the U.S. may have a link to tobacco use, according to this month's Vital Signs Report. Tobacco use is the leading preventable cause of cancer and cancer deaths. It causes more than lung cancer - based on current evidence, it can cause cancers of the mouth and throat, voice box, esophagus, stomach, kidney, pancreas, liver, bladder, cervix, colon and rectum, and a type of leukemia (acute myeloid leukemia).

Original title: “Cancers linked to tobacco use make up 40% of all cancers diagnosed in the United States - Press Release”

Puerto Rico has the lowest incidence rate of new lung cancer compared with all other races and ethnic groups in the United States, according to a study published today in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.

Original title: “Puerto Rico has lower rates of new cases of lung and breast cancer than the rest of US - Press Release”

We are deeply saddened by the passing of our friend Rosemary V. Hernandez, known to many as Rose. When smoking gave her lung cancer, she gave her story to millions, moving many to quit smoking or to never start.

Original title: “Statement from CDC Director Tom Frieden on the passing of Rosemary V. Hernandez, former Tips From Former Smokers ad participant - Media Statement”

Tobacco control efforts are having a major impact on Americans' health, a new analysis of lung-cancer data suggests. The rate of new lung cancer cases decreased among men and women in the United States from 2005 to 2009, according to a report in this week's Morbidity and Mortality Weekly Report.

Original title: “Rates of new lung cancer cases drop in U.S. men and women -Press Release”

The rates of new lung cancer cases in the United States dropped among men in 35 states and among women in 6 states between 1999 and 2008, according to a report by the Centers for Disease Control and Prevention.

Original title: “Lung cancer rates decline nationwide”

A new report from the nation's leading cancer organizations shows that, for the first time since the report was first issued in 1998, both incidence and death rates for all cancers combined are decreasing for both men and women, driven largely by declines in some of the most common types of cancer...

Original title: “Annual Report to the Nation Finds Declines in Cancer Incidence and Death Rates; Special Feature Reveals Wide Variations in Lung Cancer Trends across States”