June 2021, Vol 12, No 3

Treatment with tebentafusp (IMCgp100), a novel bispecific T-cell receptor (TCR) fusion protein, extended survival in patients with metastatic uveal melanoma, according to the results from a recent phase 3 trial.

The COVID-19 pandemic caused significant disruptions to virtually all aspects of oncology care. There has been a steep drop in cancer diagnoses and screenings—a result of shelter-in-place policies instituted early on, as well as ongoing patient fears about returning to healthcare facilities for new appointments or follow-up care. Experts predict that there will soon be a surge of patients with advanced cancer, which has the potential to overwhelm a healthcare infrastructure already stretched very thin. There are also unanswered questions regarding the role of telemedicine moving forward, as well as the use of alternate sites of care. These issues were addressed by a panel of healthcare experts during the virtual National Comprehensive Cancer Network 2021 Annual Conference.

Gastrointestinal (GI) malignancies account for 26% of the global cancer incidence and 35% of all cancer-related deaths.¹ There is an urgent need for new therapeutic options for patients with advanced disease beyond the standard, highly burdensome combinatorial approach of polychemotherapy, radiotherapy, and surgery.¹ Recent advances in tumor molecular profiling are transforming the therapeutic landscape for patients with GI cancers, allowing for prognostication and predictive risk assessment, as well as more individualized regimens that can extend survival while minimizing the side effects that have long been associated with existing “legacy” treatment options.

In recent years, the pace of innovation in healthcare has accelerated dramatically, ushering in new processes, therapies, technologies, and policies designed to increase efficiency, reduce waste, lower the cost of care, and improve clinical outcomes and quality of life for patients. However, along the way, stakeholders have encountered numerous obstacles that threaten to undermine the full potential of these advances. One of the most significant challenges is the fact that the development of innovation is frequently siloed, occurring within a specific subsector of the healthcare delivery ecosystem, with little consideration of the impact to other parts of the overall system.

On May 28, 2021, the FDA accelerated the approval of sotorasib (Lumakras; Amgen), an oral KRAS inhibitor of the RAS GTPase family, for the treatment of adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) associated with KRAS G12C mutation, as determined by an FDA-approved test, after ≥1 systemic therapies. The FDA granted sotorasib orphan drug and breakthrough therapy designations.

On May 21, 2021, the FDA accelerated the approval of amivantamab-vmjw (Rybrevant; Janssen/Johnson & Johnson), a bispecific antibody targeting mutations in the EGFR and MET pathways, for adults with non–small-cell lung cancer (NSCLC) that is associated with EGFR exon 20 insertion mutations, as detected by the FDA-approved Guardant360 CDx test, which was approved on the same day as a companion diagnostic for amivantamab. The FDA had granted amivantamab a breakthrough therapy designation for this indication.

On April 23, 2021, the FDA accelerated the approval of loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics SA), an intravenous, CD19-directed antibody and alkylating agent conjugate, for the treatment of relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma, in adults who have received ≥2 lines of systemic therapy.

On May 5, 2021, the FDA accelerated the approval of the PD-1 inhibitor pembrolizumab (Keytruda; Merck & Co), in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

On April 16, 2021, the FDA approved the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma. Nivolumab was the first immunotherapy approved by the FDA for first-line treatment of gastric cancer.

Selpercatinib (Retevmo) demonstrated antitumor activity in RET fusion–positive tumors other than lung cancer and thyroid cancer, according to interim results from the phase 1/2 LIBRETTO-001 clinical trial. Results from the trial were presented by Vivek Subbiah, MD, Medical Director, Clinical Center for Targeted Therapy, The University of Texas M.D. Anderson Cancer Center, Houston, at the 2021 virtual American Association for Cancer Research annual meeting.