Immuno-Oncology

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.

Neoadjuvant treatment with nivolumab plus platinum-based chemotherapy, followed by surgery and adjuvant nivolumab monotherapy, generated a statistically significant and clinically meaningful improvement in event-free survival vs neoadjuvant chemotherapy plus placebo, followed by surgery and adjuvant placebo, in patients with resectable stage IIA to IIIB non–small cell lung cancer.

The European Commission has approved tislelizumab monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab as adjuvant treatment for adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

Neoadjuvant treatment with the combination of nivolumab and ipilimumab led to responses and was well tolerated in patients with resectable hepatocellular carcinoma.

The Safety Monitoring Committee determined that prespecified criteria for pathologic complete response were met with the use of the PD-1 inhibitor tislelizumab alone or in combination with APL-1202 as neoadjuvant therapy in patients with muscle invasive bladder cancer.