Pipeline Report: May 2022 | articles

Galinpepimut-S in combination with the PD-1 inhibitor pembrolizumab elicited a clinical benefit in patients with Wilms’ tumor-1-positive relapsed/refractory platinum-resistant advanced metastatic ovarian cancer, according to top line-line data from a phase 1/2 trial (NCT03761914).

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.

The combination of nivolumab and axitinib achieved meaningful responses in treatment-naïve advanced renal cell carcinoma, according to results from a phase 1/2 trial (NCT03172754) presented at the 2022 Genitourinary Cancers Symposium.

The synthetic Toll-like receptor 9 agonist tilsotolimod reduced the sentinel lymph node biopsy positivity rate vs placebo in patients with localized, excised melanoma.

The FDA has placed a partial clinical hold on a phase 1 trial investigating FHD-286 as a treatment for patients with relapsed and/or refractory acute myeloid leukemia and myelodysplastic syndrome.

Sacituzumab govitecan will be further evaluated in patients with locally advanced unresectable or metastatic urothelial cancer that has progressed after prior platinum or checkpoint inhibitor therapy, as a part of the phase 3 TROPiCS-04 trial.

Investigators have initiated a phase 1 trial exploring ACLX-001, a novel CAR T-cell therapy using the ARC-SparX platform, in patients with relapsed/refractory multiple myeloma.

The combination of the TROP2-directed antibody-drug conjugate datopotamab deruxtecan and durvalumab showcased early activity with acceptable safety when used as first-line treatment in patients with locally advanced or metastatic triple-negative breast cancer, according to data from the phase 1b/2 BEGONIA trial.

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

The utilization of sabizabulin in patients with metastatic castration-resistant prostate cancer who progressed on androgen receptor-targeting therapy yielded significant and durable objective tumor responses, according to results of a phase 1b/2 trial (NCT03752099).

Infigratinib yielded notable activity and tolerability in patients with localized upper tract urothelial carcinoma harboring FGFR1/2/3 mutations.

Darolutamide was found to have a favorable safety and tolerability profile in patients with metastatic castration-resistant prostate cancer who were enrolled to the phase 1 ARAFOR study and received extended treatment with the agent for more than 4 years.

The addition of navicixizumab to paclitaxel produced encouraging responses with manageable toxicity in patients with platinum-resistant ovarian cancer irrespective of prior treatment with bevacizumab.

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.

The first-in-class, off-the-shelf therapeutic cancer vaccine VB10.16 in combination with atezolizumab generated positive responses in heavily pretreated patients with HPV16-positive advanced cervical cancer.

A novel combination comprised of the investigational bispecific antibody CTX-009 and paclitaxel was found to produce responses in 4 subtypes of biliary tract cancer with favorable safety and tolerability, according to interim results from an ongoing phase 2 trial.

The safety and efficacy of the combination of the oncolytic immunotherapy CG0070 and nivolumab is under exploration as a potential therapeutic option in patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy, as part of the phase 1b CORE-002 trial.

The investigational RNA interference therapy, ARO-HIF2, reduced levels of hypoxia inducible factor-2 alpha expression and had acceptable tolerability when used in patients with clear cell renal cell carcinoma, according to data from the phase 1b AROHIF21001 trial.