Targeted Oncology

Mayra Shanley, PhD, discussed background and future directions for evaluating IL-21 natural killer cells for the treatment of glioblastoma. | MD Anderson Cancer Center

The Promise of IL-21 Engineered NK Cells in Glioblastoma Treatment Mayra Shanley, PhD, discussed background and future directions for evaluating IL-21 natural killer cells for the treatment of glioblastoma.

The granted NXP800 orphan drug designation for the potential treatment of patients with ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.

NXP800 Gains FDA Orphan Drug Status in ARID1a-Deficient Ovarian Cancers NXP800 was granted orphan drug designation from the FDA in ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.

WATCH: Kenneth Shain, MD, PhD, discusses the rationale for giving CAR T-cell therapy in earlier lines of therapy for relapsed/refractory multiple myeloma. | Moffitt Cancer Center

Efficacy and Treatment-Free Interval Support Earlier Use of CAR T in R/R Myeloma Kenneth Shain, MD, PhD, discusses the rationale for giving chimeric antigen receptor (CAR) T-cell therapy in earlier lines of therapy for relapsed/refractory (R/R) multiple myeloma.

ICYMI: The FDA has accepted the supplemental biologics license application for nivolumab + ipilimumab in the first line for patients with unresectable hepatocellular carcinoma.

https://www.targetedonc.com/view/fda-accepts-nivolumab-ipilimumab-application-for-first-line-hcc-treatment

In this series, Jamie L. Koprivnikar, MD, discusses a case of a 70-year-old man with SF3B1+ with ring sideroblasts and discusses the approach to initial therapy in patients with lower-risk MDS who may have moderate-to-severe anemia.
WATCH NOW: https://www.targetedonc.com/view/approach-to-1l-therapy-selection-in-lr-mds

Hackensack Meridian Health

Approach to 1L Therapy Selection in LR-MDS Jamie L. Koprivnikar, MD, presents a case of a 70-year-old man with SF3B1+ MDS with ring sideroblasts and discusses the approach to initial therapy in patients with lower-risk MDS who may have moderate-to-severe anemia.

Knowledge in molecular diagnostics and cancer research is driving a new era in cancer care—precision oncology—where interventions and treatments are tailored to each patient’s disease characteristics. The US Oncology Network

Technology Drives Biomarker Testing Rates in Precision Oncology The knowledge gained from biomarker testing can help develop cancer prevention, diagnosis, and treatment strategies that specifically target a person’s cancer subtype.

Balancing access and safety in CAR T-cell therapy 🌟 Discover how monitoring practices and REMS updates are evolving and what it means for institutions in this exclusive interview with William Wesson, MD. The University of Kansas Cancer Center

https://one.targetedonc.com/launch/six.eight.penny/68b83226-1826-4093-9a1c-b8eee1ccfe70/?req.gate=GK02%3azEEl7GAzSwPjl1cxAUFFkQ%3d%3d%3a4JAaxQ9M470XYXkJwdTQbZANjEiUbpa58K5LgueuCn0hKgY2uIiGA9u%2f9r7CsvFzl9DOGzKY%2fOQJe4YaOb%2bBwnkepya4BypaSEeTk7rgwBsfAwTXqyDgGKUSitRIiiAy

The first patient with advanced with a tumor that has activating HER2 mutations has been enrolled in the phase 3 SOHO-02 trial of frontline treatment with BAY 2927088.

Enrollment Begins in Phase 3 SOHO-02 Trial of BAY 2927088 in NSCLC The phase 3 SOHO-02 trial has enrolled its first patient with advanced non–small cell lung cancer harboring activating HER2 mutations.

Hussein A. Tawbi, MD, PhD, and participants considered nivolumab/ipilimumab and nivolumab/relatlimab as options for a patient with metastatic . MD Anderson Cancer Center

Nivolumab Combinations Debated for a Patient With Metastatic Melanoma During a Case-Based Roundtable® event, Hussein A. Tawbi, MD, PhD, and participants considered nivolumab/ipilimumab and nivolumab/relatlimab as options for a patient with metastatic melanoma in the first article of a 2-part series.

The first patient has been dosed in the phase 3 HIGHLIGHT 1 trial of fezolinetant for the potential treatment of patients with moderate to severe vasomotor symptoms with breast cancer receiving adjuvant endocrine therapy.

Fezolinetant Trial for Hot Flashes in Patients With HR+ Breast Cancer Starts Enrollment The phase 3 study will investigate fezolinetant for vasomotor symptoms in patients receiving adjuvant endocrine therapy.

Anil Parwani, MD, PhD, discussed how AI can be used in medical education and training, as well as its role in personalized medicine. The Ohio State University Wexner Medical Center

https://www.targetedonc.com/view/ai-changes-the-landscape-of-cancer-diagnosis-and-pathology

Christopher Moertel, MD, discussed findings from the phase 2 ReNeu trial of mirdametinib in adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas. Masonic Cancer Center, University of Minnesota

https://www.targetedonc.com/view/study-reveals-mirdametinib-as-potential-game-changer-in-nf1-associated-pns

In this article, John M. Burke, MD, shares that as gene editing technology continues to advance, it could fundamentally change the landscape of cancer treatment. The US Oncology Network

The Promise of Gene Editing in Cancer Approaches Fruition As gene editing technology continues to advance, it could fundamentally change the landscape of cancer treatment.

The has received a new drug application for TLX101-CDx, an investigational PET imaging agent for the characterization of .

FDA to Review NDA for TLX101-CDx: A Promising Glioma Imaging Agent A new drug application for TLX101-CDx, an investigational PET imaging agent designed to differentiate progressive or recurrent glioma from treatment-related changes, has been submitted to the FDA.

The has granted priority review to the new drug application of in adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas.

Mirdametinib Scores FDA Priority Review in Neurofibromatosis Type 1 With PN Data from the phase 2 ReNeu study presented at the 2024 ASCO Annual Meeting support this priority review designation.

Habte Yimer, MD, discussed the findings from the phase 3 ALPINE trial and explored how these results are shaping clinical decisions in .

https://www.targetedonc.com/view/alpine-trial-highlights-zanubrutinib-s-advantage-in-cll

The has granted rare pediatric disease designation and orphan drug designation to INV724 for the treatment of .

INV724 Earns FDA Orphan Drug and Rare Pediatric Drug Designations in Neuroblastoma The innovative bispecific antibody INV724 targets GD2 and B7-H3 with high specificity for neuroblastoma.

The has granted an orphan drug designation to opaganib for the treatment of patients with neuroblastoma.

FDA Grants Orphan Drug Designation to Opaganib in Neuroblastoma The FDA has granted a second orphan drug designation to opaganib in oncology, this time for patients with neuroblastoma.

Zongertinib, an investigational oral therapy, was granted breakthrough therapy designation from the in adult patients with advanced, unresectable or metastatic whose tumors have activating HER2 mutations and who have received prior systemic therapy.

FDA Grants Zongertinib Breakthrough Therapy Designation in HER2-Mutant NSCLC New data on zongertinib for HER2-positive non–small cell lung cancer will be presented at the IASLC 2024 World Conference on Lung Cancer, shedding light on its potential as a novel treatment option for this patient population.

The TruSight Oncology Comprehensive test has received approval from the as a companion diagnostic for 2 important cancer indications.

https://www.targetedonc.com/view/trusight-oncology-test-receives-fda-approval-for-ntrk-and-ret-fusion-cancers

Christina Henson, MD, discussed proposed guidelines for head and neck cancer imaging to improve patient outcomes and consistency across practices. OU College of Medicine

https://www.targetedonc.com/view/improving-imaging-guidelines-for-extranodal-extension-in-head-and-neck-cancer

On September 26, 2024, the FDA’s ODAC will convene to conduct risk-benefit assessments of PD-L1 expression level cutoffs for immune checkpoint inhibitor treatment for patients with gastric, gastroesophageal, and esophageal cancers.

FDA’S ODAC to Discuss PD-L1 Levels for ICIs in Gastric and Esophageal Cancers The FDA’s Oncologic Drug Advisory Committee will meet on September 26, 2024, to discuss PD-L1 cutoffs for immune checkpoint inhibitors in gastric, gastroesophageal, and esophageal cancers.

Sonrotoclax + zanubrutinib led to promising responses and tolerability in patients with relapsed/refractory / in the phase 1 BGB-11417-101 study. Fred Hutch

Sonrotoclax With Zanubrutinib Yields Durable Responses in CLL/SLL When given in combination, sonrotoclax and zanubrutinib shows promise in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, according to data from the BGB-11417-101 study.

Belzutifan led to a significant benefit in PFS and ORR vs everolimus in patients with advanced clear cell previously treated with immune checkpoint and antiangiogenic therapies, according to data from the phase 3 LITESPARK-005 study.

Belzutifan Demonstrates Superior PFS, ORR vs Everolimus in Advanced RCC LITESPARK-005 showed that belzutifan improved progression-free survival and objective response vs everolimus in patients with advanced clear cell renal cell carcinoma previously treated with immune checkpoint and antiangiogenic therapies.

Is CAR T-cell therapy a miracle or a gamble? Discover the groundbreaking treatment's potential and risks, and learn how evolving guidelines could improve patient outcomes in this exclusive interview! The University of Kansas Cancer Center

https://one.targetedonc.com/launch/six.eight.penny/68b83226-1826-4093-9a1c-b8eee1ccfe70/?req.gate=GK01%3aYMv7%2bIf8sYd08CzJPcCd5A%3d%3d%3aHhCatSsJnVk2FYrhAXbEQz%2fcGsisXTA7%2fmZ05xHX4SOjqGWgUzoqRElE0Hfez9SmjFCrVaUVkj1UIy4NKiaUvjSYAFUEVm0w%2bQStnF%2f2TEqrVDP4dSfCQx%2bxa3RMmVZo

The has granted fast track designation to BGB-16673 for patients with relapsed/refractory or .

Novel BTK Degrader Earns FDA Fast Track Designation in CLL/SLL BGB-16673 has been granted FDA fast track designation based on findings from a phase 1/2 study of the oral agent in relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Sonrotoclax + zanubrutinib led to promising responses and tolerability in patients with relapsed/refractory / in the phase 1 BGB-11417-101 study.

Sonrotoclax With Zanubrutinib Yields Durable Responses in CLL/SLL When given in combination, sonrotoclax and zanubrutinib shows promise in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, according to data from the BGB-11417-101 study.

Findings from Arm D of the phase 3 SEQUOIA trial (NCT03336333) presented at the 2024 European Hematology Association ( ) Congress showed that the combination of zanubrutinib (Brukinsa) and venetoclax (Venclexta) achieved an impressive overall response rate (ORR) of 100% in treatment-naive patients with chronic lymphocytic leukemia ( ) or small lymphocytic lymphoma ( ) harboring 17p deletions and/or TP53 mutations!

🔍 Key Highlights:

- **Complete Response (CR) Rate**: 46%
- **CR with Incomplete Count Recovery (CRi)**: 2%
- **Partial Response (PR) Rate**: 51%
- **PR with Lymphocytosis**: 2%
- Favorable safety profile with low rates of atrial fibrillation and hypertension

These findings highlight not only the efficacy of this novel combination but also a favorable safety and tolerability profile, offering hope for many patients. What do you think about these results? How do you see the landscape of CLL treatment evolving with such promising therapies? Share your thoughts below! 💬👇

One Arm of SEQUOIA Trial Shows 100% Response in High-Risk CLL/SLL Zanubrutinib with venetoclax led to an overall response rate of 100% when used for treating patients with treatment-naive chronic lymphocytic leukemia or small lymphocytic lymphoma with 17p deletions and/or TP53 mutations.

Ian Krop, MD, PhD, discussed the use of chemotherapy in patients with HER2- and hormone receptor–positive metastatic breast cancer in combination with trastuzumab.

https://www.targetedonc.com/view/participants-consider-the-necessity-of-chemo-in-her2-breast-cancer