Immuno-Oncology | Specialty

FDA Updates PDUFA Date of BLA for Subcutaneous Nivolumab in Advanced or Metastatic Solid Tumors

May 21st 2024

The FDA has updated the PDUFA target action date for the BLA for subcutaneous nivolumab in advanced or metastatic solid tumors.

Tivumecirnon Plus Pembrolizumab Displays Activity and Tolerability in HNSCC

May 20th 2024

Jameel Muzaffar, MD, discusses findings from the phase 2 portion of the FLX475-02 study examining tivumecirnon plus pembrolizumab in HNSCC.

Telemedicine Allows for First-of-its-Kind Trial Administering Subcutaneous Immunotherapy at Home

May 17th 2024

Jorge J. Nieva, MD, details the benefits of telemedicine and a first-of-its-kind clinical trial where patients with NSCLC will receive subcutaneous immunotherapy at home.

Grivas Spotlights Advances With Immunotherapy-Based Approaches in Urothelial Cancer

May 14th 2024

Petros Grivas, MD, PhD, discusses the significance of the phase 3 JAVELIN Bladder 100, EV-302, and CheckMate 901 trials in urothelial cancer.

Relatlimab Plus Nivolumab/Chemo Misses ORR End Point in LAG-3+ Advanced Gastric/GEJ Cancer

May 14th 2024

Relatlimab plus nivolumab and chemotherapy did not improve responses in untreated advanced gastric or GEJ cancer with a LAG-3 expression of at least 1%.

Nivolumab/Chemoradiotherapy Regimen Misses PFS End Point in Unresectable, Locally Advanced NSCLC

May 10th 2024

Nivolumab plus concurrent chemoradiotherapy, followed by nivolumab plus ipilimumab, did not improve PFS in unresectable stage III NSCLC.

First-Line Versamune HPV Plus Pembrolizumab Meets BOR End Point in Recurrent/Metastatic HPV16+ HNSCC

May 10th 2024

First-line treatment with the combination of Versamune HPV and pembrolizumab met a best overall response end point in recurrent/metastatic HNSCC.

Setanaxib Plus Pembrolizumab Improves Survival in Recurrent/Metastatic HNSCC

May 7th 2024

Setanaxib plus pembrolizumab improved progression-free survival and overall survival in recurrent or metastatic head and neck squamous cell carcinoma.

Frontline Pembrolizumab Plus Trastuzumab/Chemo Meets OS End Point in HER2+ Gastric/GEJ Cancer

May 1st 2024

Frontline pembrolizumab plus trastuzumab/chemotherapy improved overall survival in HER2-positive, unresectable or metastatic gastric/GEJ cancer.

Dostarlimab/Chemo Receives FDA Priority Review for Expanded Indication in Endometrial Cancer

April 24th 2024

The FDA has granted priority review to dostarlimab plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer.

Early Data With Copanlisib/Nivolumab Combo Support Further Exploration in MSS CRC

April 18th 2024

Eric S. Christenson, MD, discusses the potential benefit of copanlisib plus nivolumab in PIK3CA-mutant microsatellite stable colorectal cancer.

Immunotherapy-Based Approaches Make Waves in Bladder Cancer

April 17th 2024

Experts highlight clinical trial updates in muscle-invasive bladder cancer, frontline treatment options in metastatic urothelial carcinoma, and more.

Clinicians Turn Their Focus to pMMR Disease Following Immunotherapy’s Entrance Into dMMR Endometrial Cancer

April 16th 2024

Exploration continues for the use of immunotherapy in patients with mismatch repair–proficient endometrial cancer.

Adjuvant Nivolumab Provides Sustained DFS Benefit, Favors OS in Muscle-Invasive Urothelial Cancer

April 16th 2024

Adjuvant nivolumab extended DFS, NUTRFS, and DMFS vs placebo and showed for the first time an improvement in OS in patients with high-risk muscle-invasive urothelial cancer.

Durvalumab Plus Chemo Sustains 3-Year OS Benefit in Advanced Biliary Tract Cancer

April 16th 2024

Durvalumab plus chemotherapy produced superior 3-year survival outcomes vs chemotherapy alone in advanced biliary tract cancer.

Nivolumab Plus Talazoparib Does Not Induce Responses in Heavily Pretreated Melanoma

April 10th 2024

Nivolumab plus talazoparib did not produce RECIST-based tumor responses in heavily pretreated patients with unresectable or metastatic melanoma.

Toripalimab Plus Axitinib Approved in China for Frontline Renal Cell Carcinoma

April 9th 2024

The NMPA of China has approved toripalimab plus axitinib for use in the first-line treatment of patients with medium- to high-risk unresectable or metastatic RCC.

China’s NMPA Grants Priority Review to Sintilimab Plus Fruquintinib in pMMR/Non–MSI-H Advanced Endometrial Cancer

April 2nd 2024

The new drug application for sintilimab plus fruquintinib has been granted priority review by the NMPA for pMMR/non-MSI-H advanced endometrial cancer.

Ongoing Trials Aim to Build on Systemic Therapy Combinations in Advanced RCC

April 1st 2024

Wenxin (Vincent) Xu, MD, shares recent updates in the treatment of renal cell carcinoma, including insights into ongoing research and trials within the space.

Immune Checkpoint Inhibitors Revolutionize Endometrial Cancer Treatment

April 1st 2024

The incorporation of immune checkpoint inhibitors has altered the treatment paradigm for endometrial cancer.