The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
DKN-01 Plus Bevacizumab/Chemotherapy Advances to Part B in DeFianCe Trial in Advanced CRC
July 13th 2023Leap Therapeutics has launched the randomized, controlled part B of the phase 2 DeFianCe trial, which will evaluate DKN-01 in combination with bevacizumab and chemotherapy as second-line therapy in patients with advanced colorectal cancer.
Novel Radiotherapy Supports Precision Medicine Advances in Lung and Bone Cancers
July 13th 2023Adnan F. Danish, MD, discusses current unmet needs in the treatment of patients with stage IV lung and bone cancers, the benefits SCINTIX technology can provide for these patients, and how John Theurer Cancer Center plans to use this technology to improve patient outcomes and support further radiation therapy research.
China’s NMPA Accepts sNDA for Frontline Toripalimab Plus Axitinib in Metastatic RCC
July 12th 2023China’s National Medical Products Administration has accepted a supplemental new drug application seeking the approval of toripalimab plus for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma
Anemia-Focused Treatment Approaches Represent Future Directions in Myelofibrosis
July 12th 2023Anna B. Halpern, MD, discusses strides in the treatment of myelofibrosis with anemia, the shifting role of ruxolitinib in this disease, and the importance of providing patients with access to clinical trials.
Trastuzumab Deruxtecan Approved in China for HER2-Low Metastatic Breast Cancer
July 12th 2023China’s National Medical Products Administration has approved trastuzumab deruxtecan monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer who have previously received a systemic therapy in the metastatic setting or whose disease recurred during or within 6 months of adjuvant chemotherapy.
FDA Accepts sBLA for Zanubrutinib Plus Obinutuzumab for R/R Follicular Lymphoma
July 12th 2023The FDA has accepted a supplemental biologics license application seeking the approval of zanubrutinib in combination with obinutuzumab in the treatment of adult patients with relapsed/refractory follicular lymphoma who received at least 2 prior lines of therapy.
Explorations Unearth New Potential of KRAS Mutations in Pancreatic Cancer
July 12th 2023As more is understood about the biology of PDAC tumors, targeting common KRAS variants in these tumors following exhaustion of all curative intent surgery, chemotherapy, and radiation ushers in a novel postadjuvant setting for investigators.
Immuno-Oncology Approaches Continue to Advance Across Gynecologic Cancers
July 11th 2023Michael J. Birrer, MD, PhD, highlights the effect of improved molecular characterization in endometrial cancer, the clinical significance of the KEYNOTE-775 trial, and recent changes in the frontline treatment landscape in advanced endometrial cancer.
LOTIS-9 Trial of Loncastuximab Tesirine/Rituximab in Untreated DLBCL Pauses Enrollment
July 11th 2023ADC Therapeutics has voluntarily paused enrollment to the phase 2 LOTIS-9 trial investigating the combination of loncastuximab tesirine and rituximab for use in unfit or frail patients with previously untreated diffuse large B-cell lymphoma.
Multiple Myeloma Treatment Advances Promote a Future of Individualized Patient Care
July 11th 2023Jeffrey V. Matous, MD, highlights takeaways from the phase 3 IKEMA trial and notes the benefits of administering CAR T-cell therapy in earlier lines, as evidenced in primary results from the phase 3 CARTITUDE-4 trial.
Fixed-Duration Glofitamab Approved in Europe for Relapsed/Refractory DLBCL
July 11th 2023The European Commission has granted conditional marketing authorization to glofitamab for fixed-duration administration in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following 2 or more lines of systemic treatment.
First-line Nivolumab Plus Chemo Provides Survival Benefit in Metastatic Urothelial Carcinoma
July 11th 2023Frontline treatment with the combination of nivolumab and cisplatin-based chemotherapy, followed by nivolumab monotherapy, led to a statistically significant improvement in PFS and OS vs standard cisplatin-based chemotherapy regimens alone in previously untreated, cisplatin-eligible patients with unresectable or metastatic urothelial carcinoma.
Negative Survival Data From CONTACT-03 Call ICI Rechallenge in Advanced RCC Into Question
July 11th 2023Toni K. Choueiri, MD, highlights findings from the CONTACT-03 trial and their clinical significance, as well as the need for continued investigation of PD-1 inhibitor rechallenge despite the negative trial results with cabozantinib and atezolizumab.
Intensified Frontline ABVD Improves PFS in Advanced Classical Hodgkin Lymphoma
July 10th 2023Dose-dense and dose-intense doxorubicin, bleomycin, vinblastine, dacarbazine, and granulocyte colony–stimulating factor (ABVD) generated an improvement in progression-free survival and other efficacy end points compared with PET-adapted ABVD in previously untreated patients with advanced classical Hodgkin lymphoma.
THIO Followed by Cemiplimab Shows Early Promise in Advanced NSCLC
July 10th 2023The sequential combination of 6-thio-2’-deoxyguanosine and cemiplimab provided a progression-free survival benefit in the first 2 patients with advanced non–small cell lung cancer enrolled to the part A safety lead-in portion of the phase 2 THIO-101 trial.
Systemic Therapy Shows Increasing Promise for CNS Metastases in Breast Cancer
July 10th 2023Nancy U. Lin, MD, provides clinical insights on the treatment of patients with breast cancer brain metastases and discusses the advantages and disadvantages of systemic therapy vs radiation therapy for this population.
Neoadjuvant Enfortumab Vedotin Continues to Elicit Encouraging Antitumor Activity in MIBC
July 10th 2023Single-agent enfortumab vedotin in the neoadjuvant setting had substantial antitumor activity and a high event-free survival rate with a manageable toxicity profile in patients with cisplatin-ineligible muscle-invasive bladder cancer.
PRT811 Showcases Early Signals of Efficacy in IDH-Mutant Glioma and Uveal Melanoma
July 10th 2023Varun Monga, MBBS, discusses the mechanism of action of PRT811, key efficacy and safety findings from a phase 1 trial investigating the agent, and potential future directions with this agent in uveal melanoma and IDH-mutant high-grade glioma.
MET+ Expression May Be Predictive of Responses With Amivantamab/Lazertinib in Post-Osimertinib NSCLC
July 10th 2023MET positivity according to immunohistochemistry showed predictive value for deriving durable responses with amivantamab plus lazertinib in patients with EGFR-mutated non–small cell lung cancer whose disease progressed on or after osimertinib and are chemotherapy naïve.
Interpreting Clinical Trial Data Is Not as Simple as It May Seem
July 10th 2023In our fast-moving world where a report of a clinically important trial finding may be simply a 60-second sound bite for both lay and medical communities, it is critical that great care must be taken that reported conclusions are understandable to all, not just the statisticians.
Trastuzumab Deruxtecan Confers Response in HER2+ Gastric/GEJ Cancer in Updated Analysis
July 10th 2023Treatment with trastuzumab deruxtecan resulted in clinically meaningful efficacy in patients with HER2-positive gastric or gastroesophageal junction cancer following disease progression on or after a trastuzumab-containing regimen.