#LDTs

On April 26, 2024, the FDA issued 3 draft guidance documents on eligibility criteria in cancer clinical trials to address:
📝 performance status
⌛ washout periods
💊 📊 concomitant medications and laboratory values
fda.gov/regulatory-inf… search 'eligibility'

In Cancer Prevention Research from Johns Hopkins Kimmel Cancer Center & MD Anderson Cancer Center #PancreaticCancer teams:
Germline Testing identifies Pathogenic/Likely Pathogenic Variants in Patients with Pancreatic Neuroendocrine Tumors
aacrjournals.org/cancerpreventi…
In an unselected population, 1 in 5 harbor germline alterations…

Out in Journal of Clinical Oncology NECTIN4 Amplification predicts Enfortumab Vedotin response in Urothelial Cancer #mUC
💊 96% response rate to EV therapy in amplified cases vs 32% in others (P < .001).
➡️Perhaps we need to look deeper than IHC for other ADCs too? 🤔 ascopubs.org/doi/full/10.12…

Just published: CAP PDL-1 and TMB testing guidelines for ICI therapy use in patients with NSCLC. #PDL1 #NSCLC

doi.org/10.5858/arpa.2…

Approximately 60% of all HER2- breast cancers are currently defined HER2-low (IHC 1+ or 2+ ISH-). This review describes how to best identify pts with HER2-low breast cancer with respect to sample type, testing methods, scoring and reporting of HER2 status. esmoopen.com/article/S2059-…

T-DXd is approved for the treatment of patients with ANY treatment-refractory HER2+ (IHC 3+) tumor, making of it the first agnostic ADC. Unlikely to be the last. Key priority: ensuring that HER2 testing is expanded across cancer types. Exciting times! fda.gov/drugs/resource…

New data from EV302 Enfortumab Vedotin & pembrolizumab for upper tract disease (~25% of pts). UTUC has distinct biological features including more FGFR alterations. PFS & OS HR of 0.50 & 0.53 respectively in the subset is in line with the whole population (0.45 and 0.47) #EAU24

Just published in CA: A Cancer Journal for Clinicians
Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries
OncoAlert
acsjournals.onlinelibrary.wiley.com/doi/10.3322/ca…
#LungCancer continues to be the #1 cause of cancer related mortality worldwide overall…

One of the more important extrapolations from the data here is that cfDNA assays (mutations or methylation) alone are quite suboptimal for sensitivity in early stage #PancreaticCancer . Criticism of CA19-9 is justified, but by themselves cfDNA assays perform worse in early stage.

Such a great example of precision medicine

In-depth genomic analysis of SCLC demonstrates that treatment-naive tumors show clonal homogeneity, but chemotherapy triggers significant genetic diversity. Effective first-line treatment is crucial in SCLC, as it shapes the genomic landscape of relapse & resistance…

New ESMO - Eur. Oncology guidlines for advanced bladder cancer Annals of Oncology. Enforumab Vedotin & pembro is the new standard of care. Platinum therapy is now 2nd line and eligibility less relevant. Gem/cis/nivo or maintenance avelumab for pts where EVP not available annalsofoncology.org/article/S0923-…

Results from phase I CLOVER study Lung Cancer Journal: concurrent durvalumab + chemoradiation for stage III NSCLC. Explored various regimens: 7.8% rate of pneumonitis, mPFS 13.4m - but we know from PACIFIC-2 press release that this is not the right strategy.

lungcancerjournal.info/article/S0169-…

#OpenAccess review in Cancer Cell from Julian Downward
Exploiting the therapeutic implications of KRAS inhibition on tumor immunity
cell.com/cancer-cell/fu…

Out now in JTO & JTO CRR excellent work from Drs. valter torri Hines, Cameron & Marina Garassino over 2500 pts in neoadjuvant & perioperative trials to date, pCR appears predictive of EFS, early days for OS. #lcsm jto.org/article/S1556-…

Register now for our live symposium on NSCLC management! Join world experts to explore molecular testing, interpretation, and treatment decisions. Don't miss out on this vital event shaping the future of lung cancer care!

#Endometriosis takes 7-10 years to diagnose, on average; but a surge in research is finally leading to new diagnostics and treatments. News feature from Clare Watson #InternationalWomensDay2024
nature.com/articles/s4159…

Take a listen to this special episode of the IASLC podcast, Lung Cancer Considered, where I discuss barriers to biomarker testing in lung cancer with Drs. Rami Manochakian MD, FASCO 🇺🇸🇸🇾CancerEducation Debora Bruno, MD Matthew Smeltzer and please complete the IASLC biomarker survey.

iaslc.org/research-educa…