Immuno-Oncology

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of subcutaneous atezolizumab for all indications in which the intravenous formulation is approved, including certain types of lung, liver, bladder, and breast cancer

Concurrent administration of durvalumab and platinum-based chemoradiation failed to significantly improve progression-free survival over chemoradiation alone in patients with unresectable stage III non–small cell lung cancer, missing the primary end point of the phase 3 PACIFIC-2 trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of pembrolizumab (Keytruda) combined with gemcitabine and cisplatin in the frontline treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer

The combination of PDS0101, PDS0301 (formerly M-9241), and bintrafusp alfa, an investigational immune checkpoint inhibitor extended survival in patients with advanced human papillomavirus 16–positive cancers, according to final data from a phase 2 trial (NCT04287868) led by the National Cancer Institute.

Durvalumab plus concurrent transarterial chemoembolization followed by durvalumab with bevacizumab resulted in a significant improvement in PFS over TACE alone in patients with hepatocellular carcinoma who are eligible for embolization, meeting the primary end point of the phase 3 EMERALD-1 trial.

The combination of domvanalimab, zimberelimab, and FOLFOX elicited responses in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, irrespective of PD-L1 status.

The addition of atezolizumab to bevacizumab and chemotherapy resulted in a significant improvement in progression-free survival and overall survival vs standard treatment with bevacizumab and chemotherapy in patients with metastatic, persistent, or recurrent cervical cancer.

Adjuvant treatment with pembrolizumab significantly improved overall survival vs placebo in patients with renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions, meeting a key secondary end point of the phase 3 KEYNOTE-564 trial.

The European Medicines Agency has validated a type II variation application for the first-line combination of nivolumab and cisplatin-based chemotherapy for adult patients with unresectable or metastatic urothelial carcinoma.

Richard Kim, MD, discusses the range of systemic treatment options available for patients with unresectable hepatocellular carcinoma and the importance of assessing patients for high-risk disease criteria before beginning any systemic treatment.

Denise M. Wolf, PhD, discusses the methods used to conduct the I-SPY2 study and the implications that immune biomarkers could have on selecting treatment for patients with hormone receptor–positive, HER2-negative breast cancer in the future.

Tian Zhang, MD, MHS, details how updated data presented at the 2023 ASCO Annual Meeting from trials such as KEYNOTE-426 and CLEAR have showed the sustained efficacy of VEGF plus immunotherapy combinations vs sunitinib in the first-line setting; discusses where the immunotherapy-only combination of ipilimumab and nivolumab fits in the frontline setting; and highlights how data from CONTACT-03 provided key insights on the use of immunotherapy in patients with advanced renal cell carcinoma after progression on a prior immune checkpoint inhibitor.

Nephrectomy with immune-targeted therapy was associated with a progression-free survival benefit compared with immunotherapy alone in patients with metastatic renal cell carcinoma.

Frontline treatment with the combination of enfortumab vedotin-ejfv and pembrolizumab led to a statistically significant improvement in overall survival vs chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

The addition of durvalumab to first-line chemotherapy, followed by maintenance treatment with durvalumab plus olaparib significantly improved progression-free survival in patients with newly diagnosed advanced or recurrent endometrial cancer, according to data from the phase 3 DUO-E/GOG-3041/ENGOT-EN10 trial.

Neoadjuvant treatment with nivolumab plus chemotherapy followed by surgery and adjuvant nivolumab resulted in a statistically significant improvement in event-free survival vs placebo plus chemotherapy, in patients with previously untreated resectable stage II to IIIB non-small cell lung cancer, according to data from the phase 3 CheckMate 77T trial.

Lifileucel demonstrated clinically meaningful activity in patients with advanced mucosal melanoma who experienced disease progression on immune checkpoint inhibitors, according to findings from a subgroup of patients in the phase 2 C-144-01 study.

Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab plus endocrine therapy generated a statistically significant increase in pathologic complete response vs neoadjuvant placebo plus chemotherapy followed by adjuvant pembrolizumab and endocrine therapy in patients with high-risk, early-stage, estrogen receptor–positive, HER2-negative breast cancer.

Treatment with subcutaneous nivolumab co-formulated with recombinant human hyaluronidase demonstrated noninferior pharmacokinetics vs intravenous nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma who received prior systemic therapy.

The FDA has approved nivolumab (Opdivo) for the adjuvant treatment of adult and pediatric patients 12 years of age and older with completely resected stage IIB or IIC melanoma.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for pembrolizumab plus fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of adult patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma.

TJ-L14B/ABL503 demonstrated preliminary efficacy signals in the form of responses in patients with progressive, locally advanced or metastatic solid tumors who were relapsed or refractory after previous lines of therapy.

Pembrolizumab plus chemotherapy prior to surgery, followed by resection and single-agent pembrolizumab in the adjuvant setting, significantly improved overall survival vs neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in patients with resectable stage II, IIIA, or IIIB (T3-4N2) non–small cell lung cancer, meeting the dual primary end point of the phase 3 KEYNOTE-671 trial.

Joachim G. J. V. Aerts, MD, PhD, discusses the rationale for conducting the phase 3 DENIM trial in patients with mesothelioma, highlighting the importance of focusing investigational efforts onto the dendritic cells.

Pembrolizumab as adjuvant therapy led to a statistically significant and clinically meaningful improvement in disease-free survival compared with observation in patients with localized muscle invasive urothelial cancer and locally advanced urothelial cancer.

Second-line treatment with NT219 alone and in combination with cetuximab demonstrated safety and tolerability, and the combination produced confirmed partial responses in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.

The addition of PDS0101 to pembrolizumab resulted in a 2-year overall survival rate of 74% in patients with unresectable, recurrent, or metastatic, HPV16-positive head and neck squamous cell carcinoma who were naïve to an immune checkpoint inhibitor.

Immunotherapy has become a valuable tool for the treatment of patients with various types of lymphomas because of its ability to specifically target cancer cells, particularly those in blood cancers.

The first-line combination of pembrolizumab, lenvatinib, pemetrexed, and platinum-containing chemotherapy did not meet the dual primary end points of overall survival and progression-free survival compared with pembrolizumab plus pemetrexed and platinum-containing chemotherapy in patients with metastatic, nonsquamous non–small cell lung cancer in whom EGFR-, ALK- or ROS1-directed therapies were not indicated.

Treatment with the combination of enfortumab Vedotin and pembrolizumab led to an improvement in overall survival and progression-free survival compared with chemotherapy in previously untreated patients with locally advanced or metastatic urothelial cancer who were eligible for cisplatin- or carboplatin-containing chemotherapy.