ASCO 2015 Highlights

On May 28, 2021, the FDA accelerated the approval of infigratinib (Truseltiq; QED Therapeutics), an oral kinase inhibitor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) and FGFR2 fusion or other rearrangement, as detected by an FDA-approved test. The FDA granted infigratinib priority and fast-track review, as well as orphan drug designation for this indication.

On July 9, 2021, the FDA accelerated the approval of a new indication for daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech), in combination with pomalidomide (Pomalyst; Bristol Myers Squibb) and dexamethasone, for the treatment of adults with multiple myeloma who have received at least 1 previous line of therapy, including lenalidomide (Revlimid) or a proteasome inhibitor.

On June 16, 2021, the FDA approved a new indication for avapritinib (Ayvakit; Blueprint Medicines) for the treatment of adults with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and mast-cell leukemia. The FDA granted this indication a priority review and breakthrough therapy and orphan drug designations.

On July 21, 2021, the FDA granted full approval for the PD-1 inhibitor pembrolizumab (Keytruda; Merck), in combination with the kinase inhibitor lenvatinib (Lenvima; Eisai), for the treatment of advanced endometrial carcinoma that is not MSI-H (microsatellite instability-high) or dMMR (mismatch repair-deficient), in patients whose disease progressed after previous systemic therapy in any setting, and who are not candidates for curative surgery or radiation.

On July 9, 2021, the FDA granted full approval to enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have received ≥1 previous lines of therapy.

The addition of the lymphocyte activation gene-3 (LAG-3)–blocking antibody relatlimab to nivolumab (Opdivo) led to significantly longer progression-free survival (PFS) compared with nivolumab alone in previously untreated patients with advanced melanoma, according to results of the phase 3 RELATIVITY-047 clinical trial presented at the ASCO 2021 virtual annual meeting.

The addition of ¹⁷⁷Lu-PSMA-617, a radionuclide therapy that targets prostate-specific membrane antigen (PSMA), to standard-of-care treatment resulted in a 38% reduction in the risk for death versus standard of care alone in men with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), according to findings from the phase 3 VISION clinical trial, which were presented during a plenary session at the ASCO 2021 virtual annual meeting.

Early results from the CheckMate-648 clinical trial, which evaluated the efficacy and safety of Opdivo (nivolumab), a PD-1 inhibitor, plus Yervoy (ipilimumab), a CTLA-4 inhibitor, or nivolumab plus chemotherapy, suggest a potential new standard of care for the first-line treatment of patients with advanced esophageal squamous-cell carcinoma (ESCC). These findings were presented at the ASCO 2021 virtual annual meeting by Ian Chau, MD, Consultant Medical Oncologist, Gastrointestinal and Haemato-Oncology, Royal Marsden Hospital, Sutton, United Kingdom, and lead investigator of the trial.

Treatment with the checkpoint inhibitor pembrolizumab (Keytruda) following surgery significantly extended disease-free survival (DFS) in patients with high-risk, clear-cell renal-cell carcinoma (RCC) compared with placebo, according to the results of the KEYNOTE-564 clinical trial. These findings were reported during a plenary session of the ASCO 2021 virtual annual meeting.

Cholangiocarcinoma (CCA) represents a group of heterogeneous cancers that originate in the bile ducts that connect the liver and gallbladder to the small intestine. Although the exact prevalence of CCA is unknown, CCA is a rare cancer; approximately 8000 new cases of CCA are diagnosed annually in the United States.