Immuno-Oncology | Specialty

FDA Approves 2 Frontline Nivolumab-Based Regimens for Unresectable Advanced or Metastatic ESCC

May 27th 2022

The FDA has approved nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, irrespective of PD-L1 status.

FDA Lifts Partial Clinical Hold on NEON-2 Trial Evaluating Davoceticept Plus Pembrolizumab in Advanced Malignancies

May 24th 2022

The FDA has lifted a partial clinical hold on the phase 1 NEON-2 trial investigating the use of davoceticept in combination with pembrolizumab in adult patients with advanced solid tumors or lymphoma.

FDA Approval Sought for N-803 Plus BCG in BCG-Unresponsive NMIBC Carcinoma in Situ

May 23rd 2022

A biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin in patients with BCG-unresponsive, non–muscle invasive bladder cancer carcinoma in situ with or without Ta or T1 disease has been submitted to the FDA.

Pembrolizumab/Chemo With or Without Bevacizumab Has Potential as New SOC in Metastatic Cervical Cancer

May 21st 2022

Nicoletta Colombo, MD, PhD, discusses the practice-changing data to emerge from KEYNOTE-826 and the next steps for the pembrolizumab plus chemotherapy with or without bevacizumab regimen in patients with cervical cancer.

Pembrolizumab Moves Toward EU Approval for Resected Stage IIB/IIC Melanoma

May 20th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use as adjuvant therapy in adult and adolescent patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.

TLR9 Agonist Vidutolimod Shows Promise in Combination With Pembrolizumab in PD-1–Refractory Melanoma

May 19th 2022

The combination of intratumoral vidutolimod and intravenous pembrolizumab demonstrated promising clinical activity in patients with PD-1 refractory melanoma.

Nivolumab/Ipilimumab Plus SBRT Shows Antitumor Activity in Refractory Pancreatic Cancer

May 18th 2022

Stereotactic body radiation therapy in combination with nivolumab and ipilimumab demonstrated clinically meaningful antitumor activity with a favorable toxicity profile in difficult-to-treat patients with refractory metastatic pancreatic cancer, although the contribution of SBRT is still unclear.

Pembrolizumab Monotherapy Adds Option in MSI-H/dMMR Endometrial Cancer

May 18th 2022

The FDA has approved pembrolizumab in patients with advanced endometrial cancer that is microsatellite instability-high or mismatch repair–deficient and who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.

Frontline Nivolumab/Ipilimumab Misses OS End Point in PD-L1+ Unresectable or Metastatic Urothelial Carcinoma

May 16th 2022

The combination of nivolumab plus ipilimumab was not found to significantly improve overall survival over standard-of-care chemotherapy when used in the first-line treatment of patients with unresectable or metastatic urothelial carcinoma with a PD-L1 expression of 1% or higher.

Nivolumab Offers Long-Term DFS Benefits in Urothelial Carcinoma

May 14th 2022

According to longer follow-up data from the phase 3 CheckMate 274 trial, patients with high-risk, muscle-invasive urothelial carcinoma continued to experience clinically meaningful improvements in disease-free survival when treated with adjuvant nivolumab vs placebo.

Sotigalimab Plus Nivolumab Shows Encouraging Activity in Anti–PD-1 Refractory Melanoma

May 13th 2022

The combination of sotigalimab and nivolumab elicited durable responses with a reasonable safety profile in patients with melanoma who were refractory to anti–PD-1 therapy, according to data from a phase 2 trial.

Vibostolimab/Pembrolizumab Combo Elicits Antitumor Activity in Metastatic Cervical Cancer

May 11th 2022

Two investigated doses of vibostolimab in combination with pembrolizumab resulted in comparable antitumor activity and safety in patients with locally advanced or metastatic cervical cancer who were naïve to PD-1/PD-L1 inhibitors, regardless of PD-L1 status.

Frontline Tiragolumab/Atezolizumab Combo Misses PFS End Point in PD-L1–High Metastatic NSCLC

May 11th 2022

The anti-TIGIT immunotherapy tiragolumab in combination with atezolizumab did not improve progression-free survival over atezolizumab alone in the first-line treatment of patients with PD-L1–high locally advanced or metastatic non–small cell lung cancer.

Nivolumab Plus Trastuzumab Deruxtecan Provides No Perceptible Clinical Benefit Over ADC Alone in Advanced HER2+ Breast Cancer

May 9th 2022

The addition of nivolumab to trastuzumab deruxtecan did not result in a marked clinical benefit in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.

Tackling the Adverse Effects of Immunotherapy

May 9th 2022

Igor Puzanov, MD, MSCI, FACP, discusses the adverse effects associated with immunotherapy and how to manage them.

Pembrolizumab Plus Chemotherapy Does Not Significantly Affect QOL in PD-L1+ TNBC

May 6th 2022

The addition of pembrolizumab to chemotherapy led to significant survival benefits without substantial deterioration in health-related quality of life among patients with treatment-naïve, PD-L1–positive advanced triple-negative breast cancer according to results from the phase 3 KEYNOTE-355 trial.

Pembrolizumab With or Without Chemo Has Increased Efficacy With Increasing PD-L1 Expression in HNSCC

May 4th 2022

Pembrolizumab with or without chemotherapy resulted in a numerically longer overall survival benefit vs cetuximab plus chemotherapy in patients with head and neck squamous cell carcinoma and a PD-L1 combined positive score (CPS) between 1 and 19, but did not improve survival in the subset with a PD-L1 CPS of less than 1.

FDA Issues Complete Response Letter to Toripalimab for Nasopharyngeal Carcinoma

May 2nd 2022

The FDA is seeking the approval of toripalimab plus gemcitabine and cisplatin in the frontline treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for use as a monotherapy in the second-line and later treatment of those with recurrent or metastatic disease.

Microbiota Modulation Offers Hope of Expanding the Benefits of Immunotherapy

April 28th 2022

Novel strategies to modulate the microbiota are now an area of robust investigation

Frontline Tislelizumab/Chemo Combo Improves OS in Advanced Esophageal Squamous Cell Carcinoma

April 27th 2022

The combination of tislelizumab and chemotherapy resulted in a significant improvement in overall survival compared with chemotherapy alone in patients with locally advanced, recurrent or metastatic esophageal squamous cell carcinoma, irrespective of PD-L1 expression.