Immuno-Oncology | Specialty

Relatlimab Plus Nivolumab Approaches EU Approval for Advanced Melanoma With PD-L1 of <1%

July 23rd 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of the fixed-dose combination of nivolumab and relatlimab for the frontline treatment of adult and adolescents who are 12 years of age or older with advanced melanoma and a tumor cell PD-L1 expression of less than 1%.

Pembrolizumab Plus Chemoradiation Misses EFS End Point in Head and Neck Squamous Cell Carcinoma

July 20th 2022

Pembrolizumab plus concurrent chemoradiation followed by pembrolizumab maintenance did not lead to a statistically significant improvement in event-free survival vs concurrent chemoradiation alone in patients with unresected locally advanced head and neck squamous cell carcinoma.

FDA Defers Action on BLA for Tislelizumab in Second-Line Esophageal Squamous Cell Carcinoma

July 14th 2022

The FDA has deferred action on the biologics license application seeking the approval of tislelizumab as a second-line treatment in patients with unresectable or metastatic esophageal squamous cell carcinoma, citing the inability to conduct required inspections in China because of travel restrictions associated with COVID-19.

Nivolumab Plus Ipilimumab Displays Durable Benefit in MSI-H/dMMR mCRC

July 8th 2022

Nivolumab alone or in combination with ipilimumab continued to demonstrate sustained clinical benefit as second- and first-line therapy, respectively, in patients with microsatellite instability–high and mismatch repair deficient metastatic colorectal cancer.

Dostarlimab Produces Durable Responses With Acceptable Safety in dMMR Solid Tumors

July 8th 2022

Thierry André, MD, discusses the results of the phase 1 GARNET study with dostarlimab and the significance of these findings for patients with mismatch repair–deficient/microsatellite instqability–high solid tumors.

Durvalumab Plus Chemotherapy Improves pCR in Resectable NSCLC

June 30th 2022

Neoadjuvant treatment with durvalumab plus platinum-based chemotherapy led to a statistically significant improvement in pathologic complete response and major pathologic response compared with chemotherapy alone in patients with resectable non–small cell lung cancer, according to findings from a planned interim analysis of the phase 3 AEGEAN trial.

Botensilimab/Balstilimab Combo Produces Deep Responses in Microsatellite Stable CRC

June 29th 2022

The combination of botensilimab and balstilimab elicited deep objective responses with evidence of durability and encouraging tolerability in heavily pretreated patients with microsatellite stable, metastatic colorectal cancer.

Atezolizumab Does Not Improve pCR in HER2-Positive Early Breast Cancer

June 29th 2022

Adding atezolizumab to neoadjuvant standard of care therapy for HER2-positive early breast cancer did not result in a better pathologic complete response compared with placebo, according to findings from the phase 3 IMpassion050 trial.

Anlotinib/Sintilimab Combo Confers Long-Term OS Benefit in Advanced Cervical Cancer

June 27th 2022

The combination of anlotinib and sintilimab was found to provide a long-term survival benefit to patients with previously treated advanced cervical cancer.

Adjuvant Pembrolizumab Wins European Approval for Stage IIB/IIC Melanoma Following Complete Resection

June 24th 2022

The European Commission has approved pembrolizumab for adjuvant treatment of adult and adolescent patients 12 years and older with stage IIB or IIC melanoma who have undergone a complete resection.

T-VEC Plus Pembrolizumab Generates Promising Responses, Safety in PD-1–Refractory Advanced Melanoma

June 20th 2022

Adding talimogene laherparepvec to pembrolizumab led to encouraging responses with a manageable safety profile in patients with advanced melanoma who progressed on prior anti–PD-1 therapy, most notably in the adjuvant setting, according to findings from the phase 2 MASTERKEY-115 trial.

FDA Grants Fast Track Status to PDS0101/Pembrolizumab Combo for Recurrent or Metastatic, HPV16+ Head and Neck Cancer

June 16th 2022

The FDA has granted a fast track designation to PDS0101 for use in combination with pembrolizumab in patients with recurrent or metastatic HPV16-positive head and neck cancer.

Cosibelimab Continues to Show Promise in Locally Advanced Cutaneous Squamous Cell Carcinoma

June 16th 2022

The PD-L1 antibody cosibelimab was found to elicit an encouraging objective response rate in patients with locally advanced cutaneous squamous cell carcinoma who were not eligible to undergo curative surgery or radiation.

Immunotherapy Combinations Contribute to Efficacy and Safety Advances in Genitourinary Cancer Treatment

June 16th 2022

New treatment strategies with immunotherapeutic agents are challenging standards of care and prolonging survival in first and later lines of metastatic urothelial carcinoma, metastatic renal cell carcinoma, and metastatic castration-resistant prostate cancer.

Quavonlimab/Pembrolizumab Combo Shows Modest Antitumor Activity in Advanced Melanoma

June 16th 2022

The combination of quavonlimab and pembrolizumab was found to be generally well tolerated and to have modest antitumor activity in patients with advanced melanoma that progressed on a PD-1/PD-L1 inhibitor, according to data from a phase 1/2 trial (NCT03179436).

Nivolumab/Ipilimumab and Nivolumab/Chemo Indications Enhance ESCC Treatment Landscape

June 15th 2022

The approval of 2 nivolumab-containing combinations for patients with advanced or metastatic esophageal squamous cell carcinoma have opened the doors for immunotherapy to enter the landscape for this population allowing clinicians options to help patients to meet their individual treatment goals.

Galinpepimut-S Plus Nivolumab Extends Survival in Malignant Pleural Mesothelioma

June 14th 2022

The combination of galinpepimut-S and nivolumab was found to extend survival in patients with malignant pleural mesothelioma who were either refractory to, or who had relapsed after, at least 1 line of standard therapy.

Adjuvant Atezolizumab Approved in Europe for High-Risk NSCLC With PD-L1 of ≥50%

June 14th 2022

The European Commission has approved atezolizumab for use as an adjuvant treatment following complete resection and platinum-based chemotherapy in adult patients with non–small cell lung cancer and a high risk of recurrence whose tumors do not have EGFR mutations or ALK alterations but have a PD-L1 expression of 50% or higher.

Immunotherapeutics Aim for Larger Role in Prostate Cancer

June 9th 2022

Highly effective tools, such as immunotherapeutic agents, have emerged for the treatment of patients with a wide range of malignancies.

Adjuvant Pembrolizumab Results in Significant DMFS Improvement Over Placebo in Stage II Melanoma

June 5th 2022

Adjuvant pembrolizumab was found to result in a significant improvement in distant metastasis-free survival compared with placebo, with a continued reduction in risk of recurrence and an acceptable safety profile, in patients with resected stage IIB or stage IIC melanoma.