Nivolumab Plus Fluoropyrimidine and Platinum-Based Chemotherapy and Nivolumab Plus Ipilimumab Approved for Esophageal Squamous Cell Carcinoma

The FDA has approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with fluoropyrimidine with platinum-based chemotherapy, and nivolumab in combination with ipilimumab (Yervoy®, Bristol Myers Squibb) for treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). "Esophageal cancer causes more than half a million cancer-related deaths worldwide each year, with squamous cell carcinoma accounting for approximately 85% of cases," wrote Yuichiro Doki, MD, ...

Continue reading

Combination of Nivolumab and Relatlimab Approved for Unresectable or Metastatic Melanoma

The FDA has approved the combination of nivolumab and relatlimab-rmbw (Opdualag™, Bristol-Myers Squibb) for patients with unresectable or metastatic melanoma. OpdualagTM is a fixed-dose dual immunotherapy combination of nivolumab, a programmed cell death protein 1 (PD-1)–blocking antibody, and relatlimab, a first-in-class human lymphocyte–activation gene 3 (LAG-3)–blocking antibody, and is administered as a single intravenous (IV) infusion. "LAG-3 and PD-1 are distinct inhibitory immune checkpoi...

Continue reading

FDA Approves Nivolumab as Neoadjuvant Therapy for Resectable Non–Small Cell Lung Cancer

 The FDA has approved nivolumab (Opdivo®, Bristol-Myers Squibb) in combination with platinum doublet chemotherapy for the treatment of adult patients with early-stage, resectable non–small cell lung cancer (NSCLC). Nivolumab is a fully human programmed cell death ligand 1 (PD-L1)–targeted antibody, and its use is approved without regard for PD-L1 expression level. "In patients with nonmetastatic NSCLC, surgery has curative potential, but 30% to 80% who undergo resection experience recurrenc...

Continue reading

FDA Approves Nivolumab for High-Risk Urothelial Carcinoma

The FDA has granted regular approval to nivolumab (Opdivo®, Bristol Myers Squibb) as adjuvant therapy for patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection. This is the first time the FDA has approved an adjuvant treatment for patients with high-risk urothelial carcinoma. Nivolumab had previously been granted accelerated approval for advanced and metastatic urothelial cancer. "In a phase 3, multicenter, double-blind, randomized, controlled t...

Continue reading

Single-Agent Nivolumab Withdrawn for Hepatocellular Carcinoma Treatment

In consultation with the FDA, Bristol Myers Squibb has voluntarily withdrawn nivolumab (Opdivo®) as a single-agent treatment for patients with hepatocellular carcinoma (HCC) who had previously been treated with sorafenib. Nivolumab had previously been granted accelerated approval from the FDA in 2017, which was based on the phase 1/2 CheckMate 040 clinical trial (NCT01658878). The withdrawal of this treatment is due to the lack of statistical significance in the final overall survival results of...

Continue reading

Nivolumab/Ipilimumab for Malignant Pleural Mesothelioma: Paul Baas, MD, PhD

The FDA recently approved nivolumab/ipilimumab for the first-line treatment of malignant pleural mesothelioma, marking the second FDA approval for this condition and the first approval in the past 16 years. In this interview, Paul Baas, MD, PhD, principal investigator of the CheckMate 743 trial (NCT02899299), on which the approval was based, speaks with Oncology Data Advisor about the benefits and tolerability of nivolumab/ipilimumab, ongoing research advances in the treatment of malignant pleur...

Continue reading

Nivolumab/Cabozantinib for Renal Cell Carcinoma: David Braun, MD, PhD, and Wenxin (Vincent) Xu, MD

Recently, the results of a phase 3 trial on nivolumab/cabozantinib were published in the New England Journal of Medicine. The study (CheckMate 9ER) compared the efficacy and safety of nivolumab/cabozantinib with those of sunitinib in adult patients with previously untreated advanced clear cell renal cell carcinoma (RCC). The trial results demonstrated that nivolumab/cabozantinib has significant benefits over sunitinib in this patient population. In this interview with Oncology Data Advisor, Dr. ...

Continue reading

Nivolumab Effective for Relapsed Malignant Mesothelioma

In patients with relapsed malignant mesothelioma, nivolumab improves both overall and progression-free survival with a tolerable safety profile, according to results of the phase 3 CONFIRM trial recently presented at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer. "Malignant mesothelioma is an intractable cancer," write the investigators, led by Dean Fennell, PhD, FRCP, Chair of Thoracic Medical Oncology at Leicester Cancer Research Centre in t...

Continue reading

Advanced Renal Cell Carcinoma: Nivolumab/Cabozantinib Approved

The FDA has approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with cabozantinib (Cabometyx®, Exelixis) for patients with advanced renal cell carcinoma (RCC) receiving their first line of therapy. "As monotherapies, nivolumab and cabozantinib have demonstrated efficacy and a manageable safety profile in advanced RCC," wrote Toni Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and colleagues in their abstract of results from the...

Continue reading

Nivolumab/Ipilimumab for Advanced Renal Cell Carcinoma: Meredith Regan, ScD

Patients with advanced renal cell carcinoma (RCC) who receive combination PD-1/CTLA-4 blockade can experience periods of durable benefit and toxicity after treatment discontinuation. According to results of the phase 3 CheckMate 214 trial presented by Meredith Regan, ScD, at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, nivolumab/ipilimumab prolongs treatment-free survival, both with and without toxicity, in patients with previously untreated advanced clear cell RCC. In...

Continue reading

Nivolumab/Ipilimumab Approved: Malignant Pleural Mesothelioma

The FDA has now approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with ipilimumab (Yervoy®, Bristol-Myers Squibb) as first-line treatment for unresectable malignant pleural mesothelioma (MPM). This therapeutic combination is only the second treatment to be FDA approved for this condition, and it marks the first mesothelioma approval to take place in the past 16 years. The approval was based on efficacy data from the open-label phase 3 CHECKMATE 743 trial (NCT02899299), ...

Continue reading

Nivolumab Plus Chemotherapy for Gastric/Gastroesophageal Junction Cancer: Kohei Shitara, MD

In advanced gastric cancer and gastroesophageal junction cancer, treatment options remain limited. Results of the phase 3 CheckMate 649 and phase 2/3 ATTRACTION-4 studies, both of which investigated chemotherapy with or without nivolumab in patients with previously untreated unresectable, advanced, or recurrent gastric/gastroesophageal junction (G/GEJ) cancer, were recently presented at the European Society of Medical Oncology (ESMO) Virtual Congress 2020. CheckMate 649 reported significant impr...

Continue reading

Neoadjuvant Ipilimumab/Nivolumab for Locally Advanced/Oligometastatic Melanoma: Emilia Cocorocchio, MD

With high rates of metastasis and progression, locally advanced/oligometastatic melanoma is a challenging disease to treat. According to results of a trial recently presented at the European Medical Society for Oncology (ESMO) Virtual Congress, neoadjuvant ipilimumab/nivolumab is a safe and effective treatment for patients with this disease. In this interview with i3 Health, lead study author Emilia Cocorocchio, MD, discusses the benefits of neoadjuvant ipilimumab/nivolumab and shares advice for...

Continue reading

Melanoma With Brain Metastases: Nivolumab/Ipilimumab Effective

Nivolumab/ipilimumab demonstrates efficacy in patients with melanoma and brain metastases, according to results of the primary analysis of the phase 3 NIBIT-M2 trial, presented at the European Society of Medical Oncology (ESMO) Virtual Congress 2020. "Brain metastases represent a high unmet medical need, in which the therapeutic potential of immune-checkpoint(s) is being actively investigated," note the investigators in their presentation abstract, led by Anna Di Giacomo, MD, Associate Director ...

Continue reading

Advanced Renal Cell Carcinoma: Nivolumab/Ipilimumab Improves Treatment-Free Survival

Nivolumab/ipilimumab prolongs treatment-free survival with and without toxicity in patients with untreated advanced renal cell carcinoma (RCC), according to an updated analysis of the phase 3 CheckMate 214 trial presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. "Conventional measures may not fully characterize the impact of immuno-oncology agents," comment the investigators in their presentation abstract, led by first author Meredith Regan, ScD, Associate Profe...

Continue reading

Neoadjuvant Nivolumab/Ipilimumab for Oral Cavity SCC: Jonathan Schoenfeld, MD, MPH

Due to intensive treatments, severe side effects, and a high rate of recurrence, oral cavity squamous cell carcinoma (SCC) is a challenging disease associated with poor outcomes. According to a recent study, neoadjuvant nivolumab alone or in combination with ipilimumab may be a safe and effective treatment for patients with oral cavity SCC undergoing surgical resection. In this interview, Jonathan Schoenfeld, MD, MPH, Associate Professor of Radiation Oncology at Harvard Medical School and first ...

Continue reading

Neoadjuvant Nivolumab/Ipilimumab Effective for Oral Cavity Squamous Cell Carcinoma

In the neoadjuvant setting, nivolumab alone and in combination with ipilimumab is effective and tolerable for patients with previously untreated squamous cell carcinoma (SCC) of the oral cavity, according to results of a phase 2 trial. Surgical resection followed by adjuvant treatment is the standard of care for locally advanced oral cavity SCC. However, immunotherapies such as nivolumab and ipilimumab have recently demonstrated potential for tumor debulking in the neoadjuvant setting, thereby i...

Continue reading

Ken Kato, MD, PhD: FDA Approval of Nivolumab for Esophageal Squamous Cell Carcinoma

The FDA recently approved nivolumab for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior fluoropyrimidine- and platinum-based chemotherapy. Ken Kato, MD, PhD, lead author on the study the approval was based on, spoke to i3 Health about the challenges of treating this patient population, in addition to the significance of this approval. What are the most challenging aspects of treating patients with advanced ESCC refra...

Continue reading

FDA Approves Nivolumab/Ipilimumab/Platinum-Doublet Chemotherapy: NSCLC

Nivolumab (Opdivo®, Bristol Myers Squibb) plus ipilimumab (Yervoy®, Bristol Myers Squibb) in combination with 2 cycles of platinum-doublet chemotherapy has been FDA approved for treatment-naive patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Approval was based on the randomized, open-label trial CHECKMATE-9LA (NCT03215706). A total of 719 patients with met...

Continue reading

Nivolumab/Ipilimumab Approved for Metastatic Non-Small Cell Lung Cancer

For patients with advanced non-small cell lung cancer (NSCLC) that test positive for programmed death-ligand 1 (PD-L1), the FDA just approved an effective treatment: nivolumab (Opdivo ®, Bristol Myers Squibb) plus ipilimumab (Yervoy®, Bristol Myers Squibb). A companion diagnostic, PD-L1 IHC 28.8 pharmDx (Agilent Technologies, Inc.), was also FDA approved for selecting patients with NSCLC for treatment with nivolumab/ipilimumab. Previously approved to treat advanced kidney cancer, advanced liver ...

Continue reading

Copyright © 2022 Oncology Data Advisor. All rights reserved.