Immuno-Oncology | Specialty

FDA Approval Sought for Subcutaneous Daratumumab Plus VRd in Transplant-Ineligible or -Deferred, Newly Diagnosed Myeloma

September 30th 2024

A sBLA has been submitted to the FDA for subcutaneous daratumumab plus VRd in ASCT-ineligible or -deferred multiple myeloma.

The OncFive: Top Oncology Articles for the Week 9/22

September 28th 2024

The FDA’s ODAC votes against the risk:benefit profile of frontline PD-1 inhibitors in select tumor types, osimertinib gains approval for select NSCLC, and more this week from OncLive.

ODAC Votes Against Risk:Benefit Profile of Frontline Anti–PD-1 Therapy in Metastatic/Unresectable ESCC With a PD-L1 Expression Under 1

September 26th 2024

The FDA’s ODAC voted against the risk:benefit profile of anti–PD-1 therapy in first-line metastatic ESCC with a PD-L1 of less than 1.

ODAC Votes Against Risk:Benefit Profile of Frontline PD-1 Inhibitors in HER2–, MSS Gastric/GEJ Adenocarcinoma With a PD-L1 Expression Under 1

September 26th 2024

The FDA’s ODAC voted against the risk:benefit profile of PD-1 inhibitors in first-line advanced gastric/GEJ adenocarcinoma with a PD-L1 of less than 1.

Fixed-Dose Favezelimab Combo Fails to Improve OS in Pretreated, PD-L1+, MSS mCRC

September 25th 2024

The combination of favezelimab and pembrolizumab failed to improve OS vs regorafenib or TAS-102 in pretreated patients with PD-L1–positive, MSS mCRC.

No Significant PFS Association Is Seen Between Chemotherapy Backbone and HRD Status in First-Line TNBC

September 25th 2024

A statistically significant difference in PFS was not observed between chemotherapy backbone and HRD status in first-line TNBC.

The OncFive: Top Oncology Articles for the Week of 9/15

September 21st 2024

Adjuvant ribociclib receives FDA approval for HR+ breast cancer, AMG 193 elicits responses in MTAP-deleted solid tumors, and more this week from OncLive.

Pembrolizumab-Based Regimens Earn Positive CHMP Opinion in Endometrial and Cervical Cancers

September 20th 2024

The CHMP has issued positive opinions for 2 pembrolizumab-based regimens for select patients with endometrial and cervical cancers.

FDA Approves Pembrolizumab Plus Chemo for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

September 17th 2024

The FDA has approved frontline pembrolizumab plus chemotherapy for use in unresectable advanced or metastatic malignant pleural mesothelioma.

Addition of Perioperative Durvalumab to Neoadjuvant Chemo Generates Survival Benefits in Cisplatin-Eligible MIBC

September 15th 2024

NIAGARA was the first phase 3 study to evaluate perioperative immunotherapy plus neoadjuvant chemotherapy in cisplatin-eligible muscle-invasive bladder cancer.

Long-Term KEYNOTE-006 Data Support Pembrolizumab as SOC in Advanced Melanoma

September 15th 2024

Pembrolizumab continued to demonstrate improved survival vs ipilimumab in unresectable stage III or IV melanoma.

KEYNOTE-A18 Data Support Pembrolizumab Plus Chemoradiotherapy as New SOC in High-Risk Locally Advanced Cervical Cancer

September 14th 2024

Pembrolizumab plus chemoradiotherapy improved survival in previously untreated, high-risk locally advanced cervical cancer.

Tivozanib Monotherapy Bests Lower-Dose Tivozanib Plus Nivolumab in Metastatic RCC

September 13th 2024

The addition of nivolumab to tivozanib did not improve outcomes in metastatic RCC and 1.34 mg of tivozanib monotherapy may be considered as a second-line therapy.

Adjuvant Durvalumab Fails to Boost DFS in Resected NSCLC, Irrespective of PD-L1 Status

September 13th 2024

Adjuvant durvalumab did not provide a disease-free survival advantage over placebo in patients with NSCLC across different PD-L1 subgroups.

FDA Approves Subcutaneous Atezolizumab and Hyaluronidase-tqjs for Use in All Indications of IV Atezolizumab

September 12th 2024

The FDA has approved subcutaneous atezolizumab for use in all indications as the intravenous formulation.

Histologic Features, Risk Help Reduce Uncertainties Around Frontline Treatment Selection in RCC

September 12th 2024

Adam E. Singer, MD, PhD, details how he selects between the available TKI/IO combinations and the only dual immunotherapy regimen for patients with RCC.

Immunotherapy Could Represent New Treatment Avenue in T-Cell Lymphoma

September 5th 2024

The investigation of treatments harnessing the immune system in patients with T-cell lymphoma could lead to "a new era" of therapy for this patient population.

Novel Targets, Classes of Agents Could Refine Checkpoint Inhibition in NSCLC

September 4th 2024

Solange Peters, MD, PhD, discusses ways to refine checkpoint inhibition in the treatment of non–small cell lung cancer.

OncLive’s August Roundup of Key FDA Approvals in Oncology

September 4th 2024

Here is your snapshot of all therapeutic options that the FDA approved in August 2024 and their clinical implications.

Treatment Advances Underscore Need for MMR/MSI Testing in Advanced Endometrial Cancer

August 26th 2024

Bhavana Pothuri, MD, discusses real-world testing patterns for MMR/MSI status in patients with advanced endometrial cancer.