1516 Background: The Veteran Affairs Nebraska Western Iowa Health Care System (VA-NWIHCS) utilizes teleoncology and remote chemotherapy services to expand care to veterans in rural Nebraska who have difficulty accessing the primary campus in Omaha. Remote sites in Lincoln (60 miles) and Grand Island (GI) (150 miles) facilitate remote chemotherapy administration with oversight from oncologists in Omaha. This study compares clinical outcomes in patients receiving care at these remote sites to those in Omaha. Methods: Data were retrospectively reviewed for 151 patients receiving first-line chemotherapy at VA sites in Omaha, Lincoln or GI between 1/1/2018-12/31/2020. Data collected included age, gender, performance status, comorbidities, overall survival (start of treatment to death/last contact), malignancy type and stage, number of delayed or missed treatment cycles, chemotherapy-related toxicities, and emergency room (ER) visits or hospitalizations. SAS version 9.4 was used for analysis. Results: The study population included 108 patients who received their chemotherapy infusions in Omaha, while 43 received their infusions at the remote sites. The demographics of the patients at both Omaha and remote sites (Lincoln/GI) was predominantly male, 96% vs 91% respectively; median age was 69 years in each group; 82% vs 93% (p = 0.24) had an ECOG PS of 0-1. The two groups were comparable in terms of common comorbidities: chronic obstructive pulmonary disease (36% vs 37% p = 0.90); chronic kidney disease (38% vs 28% p = 0.24); coronary artery disease (41% vs 19% p = 0.01). Groups had a similar proportion of patients with stage IV disease (39% vs 33%; p = 0.54), treatment with curative intent (60% vs 51%; p = 0.32), and most prevalent cancers: head/neck (14% vs 12% p = 0.80), lung (25% in each p = 0.99), and gastrointestinal (10% vs 14% p = 0.57). There was no difference in median OS between the on-site treatment and remote treatment groups [96.8 (n = 84) vs 92.4 (n = 32) months (p = 0.92) for patients with solid tumors; 67.7 (n = 24) vs 94.3 (n = 11) months (p = 0.73) for hematologic malignancies]. Chemotherapy-related toxicities were noted in 61% vs 53% of patients (p = 0.39) in Omaha vs remote sites, including febrile neutropenia (6% vs 2% p = 0.99), neutropenia (6% vs 5% p = 0.67), other cytopenia (11% vs 14% p = 0.59), dehydration (9% vs 2% p = 0.18), nausea (5% vs 7% p = 0.69), and neuropathy (3% vs 7% p = 0.35). At least one hospitalization occurred in 33% vs 21% (p = 0.13) of patients and at least one ER visit in 42% vs 26% (p = 0.07). A delay in at least one treatment cycle occurred in 29% vs 21% (p = 0.32) of cases and at least one cycle of treatment was missed in 15% vs 19% (p = 0.59). Conclusions: The evaluated outcomes in oncology patients treated in Omaha versus remote sites via telemedicine under the same providers were similar. Effective oncology care, including parenteral chemotherapy administration, can be provided via telemedicine and this model can help mitigate issues with access to care.

Mobocertinib is an oral tyrosine kinase inhibitor (TKI) that selectively targets epidermal growth factor receptor exon 20 insertion (EGFRex20ins) mutations. It is a structural analog of the third-generation TKI osimertinib, which targets EGFR T790M mutant non-small cell lung cancer (NSCLC); however, mobocertinib gains selectivity for EGFRex20ins mutants over wild type (WT) by interacting with the C790 gatekeeper residue of EGFR. This is accomplished via a carboxylated isopropyl ester moiety at the C5-position of mobocertinib’s central pyrimidine core. In Phase 1/2 dose-escalation and dose-expansion studies, mobocertinib was found to have an investigator-confirmed overall response rate (ORR) of 56% (9/16; 95% CI: 30–80%) and 25% (3/12; 95% CI: 5–57%) in patients without and with baseline brain metastasis, respectively. Median investigator-assessed progression-free survival (mPFS) was 10.2 months (95% CI: 5.6 – not reached) and 3.7 months (95% CI: 1.8–15.9) in patients without and with baseline brain metastasis, respectively. A third phase evaluated patients who had received pre-treatment with platinum-based chemotherapy (PPP) and included an extension cohort (EXCLAIM cohort) which evaluated patients treated previously with 1 or 2 lines of therapy. An Independent Review Committee (IRC) found both cohorts to have similar outcomes in terms of ORR, median time to response, mPFS, and disease progression or death. The treatment-emergent adverse events (TEAE) related to mobocertinib are similar to other EGFR inhibitors and are predominately gastrointestinal (eg diarrhea, nausea, vomiting) and cutaneous (eg rash). In September 2021, the FDA granted accelerated approval for mobocertinib in the treatment of patients with locally advanced or metastatic NSCLC with EGFRex20ins mutation whose disease progressed while on platinum-based chemotherapy. The present review describes data that led to the approval of mobocertinib.