Caroline Seymour

The FDA has granted a fast track designation to the T-cell therapy BST02 for the treatment of patients with all forms of liver cancer.

VDA-1102 led to an objective response rate of 56% in patients with mycosis fungoides, according to findings from an interim analysis of a phase 2a study.

Enfortumab vedotin plus pembrolizumab showed consistent overall survival and progression-free survival benefit in all patients enrolled in EV-302.

NICE has recommended talazoparib for the treatment of patients with advanced or metastatic HER2-negative breast cancer with germline BRCA1/2 mutations.

PFS was significantly improved with durvalumab plus bevacizumab and TACE vs TACE alone in patients with unresectable HCC eligible for embolization.

The FDA has granted an orphan drug designation to PTX-252 for the treatment of patients with acute myeloid leukemia.

Treatment with THIO followed by cemiplimab-rwlc led to a high DCR regardless of dose level in patients with pretreated non–small cell lung cancer.

Treatment with TLD-1433 led to 6-, 12-, and 15-month CR rates of 54%, 38%, and 37%, respectively, in patients with non–muscle invasive bladder cancer.

Tamibarotene plus venetoclax/azacitidine elicited higher responses rates vs venetoclax/azacitidine in RARA-overexpressed acute myeloid leukemia.

The European Commission granted marketing authorization for SC atezolizumab co-formulated with Enhanze for all approved indications of IV atezolizumab.

Treatment with JBI-802, the first-in-class CoREST inhibitor with dual LSD1 and HDAC6 activity was shown to be safe and active.

The FDA has granted fast-track status to RC88 for use in patients with platinum-resistant recurrent epithelial ovarian cancer.

The FDA has accepted the filing of an ANDA for Lutetium Lu 177 Dotatate indicated for patients with gastroenteropancreatic neuroendocrine tumors.

The FDA has issued a CRL to the zolbetuximab BLA for patients with HER2- gastric or GEJ junction adenocarcinoma whose tumors are Claudin18.2 positive.

Significant tumor necrosis greater than 70% occurred in 3 patients with resectable hepatocellular carcinoma following neoadjuvant treatment with low-dose stereotactic body radiation therapy and cemiplimab-rwlc and adjuvant cemiplimab.

A biologics license application seeking the approval of the investigational positron emission tomography imaging agent 89Zr-DFO-girentuximab in clear cell renal cell carcinoma has been submitted to the FDA.

The phase 3 RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab in patients with microsatellite stable metastatic colorectal cancer will be discontinued due to futility.

David P. Carbone, MD, PhD, sought to transform lung cancer care and did it—but didn’t anticipate the personal journey it would put him on.

Findings from the EV-302 trial presented at the 2023 ESMO Congress revealed that the combination of enfortumab vedotin and pembrolizumab may become the preferred frontline standard of care for patients with locally advanced or metastatic urothelial cancer regardless of cisplatin eligibility.

The FDA has approved label updates for zanubrutinib to include data from the ALPINE trial in relapsed/refractory chronic lymphocytic leukemia, and axicabtagene ciloleucel to include findings from the primary overall survival analysis of the ZUMA-7 trial in relapsed/refractory large B-cell lymphoma.

A supplemental biologics license application and new drug application seeking the approval of amivantamab plus lazertinib as frontline therapy for the treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations have been submitted to the FDA.

The FDA has approved enfortumab vedotin in combination with pembrolizumab for patients with locally advanced or metastatic urothelial cancer.

The combination of pembrolizumab and lenvatinib failed to produce a statistically significant improvement in progression-free survival and overall survival vs platinum-based chemotherapy with carboplatin and paclitaxel as frontline therapy in patients with advanced or recurrent endometrial cancer whose disease in mismatch repair proficient/not microsatellite instability–high or mismatch repair deficient.

The FDA has approved belzutifan (Welireg) for the treatment of patients with advanced renal cell carcinoma (RCC) following a PD-1 or PD-L1 inhibitor and a VEGF TKI.

Idecabtagene vicleucel has received marketing and manufacturing approval in Japan for its supplemental new drug application in patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy.

The FDA has accepted and granted priority review to the biologics license application seeking the approval of tarlatamab for the treatment of patients with advanced small cell lung cancer.

DZD8586 showcased antitumor activity and favorable safety with limited grade 3 or greater treatment-emergent adverse effects in patients with heavily pretreated B-cell non-Hodgkin lymphoma, according to preliminary findings from a pooled analysis of two ongoing phase 1 trials.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 ASH Annual Meeting. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.

Induction therapy with subcutaneous daratumumab followed by autologous stem cell transplant, daratumumab, bortezomib, lenalidomide, and dexamethasone consolidation and daratumumab/lenalidomide maintenance prolonged progression-free survival in patients with newly diagnosed, transplant-eligible multiple myeloma.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 ASH Annual Meeting. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.