Noted This Week
AMG 510 is a promising therapy in patients with KRAS G12C–mutant non–small cell lung cancer (NSCLC), according to findings presented at the 2019 World Conference on Lung Cancer (WCLC) in Barcelona, Spain. In a phase I trial, seven of 13 evaluable patients with NSCLC had a partial response to the small-molecule inhibitor, and six more achieved stable disease. The results build on initial data presented at the 2019 American Society of Clinical Oncology Annual Meeting.
Also at the WCLC, Loxo Oncology announced that the RET inhibitor selpercatinib (LOXO-292) may be effective in patients with RET fusion–positive NSCLC. In the LIBRETTO-001 trial, the drug elicited an objective response rate (ORR) of 68% in 105 previously treated patients, and an ORR of 85% in 34 newly diagnosed patients. The drug was also generally well tolerated.
AstraZeneca’s durvalumab (Imfinzi) may improve survival of patients with newly diagnosed extensive-stage small cell lung cancer (SCLC), researchers reported at the WCLC. In the phase III CASPIAN trial, patients treated with the PD-L1 inhibitor plus chemotherapy had a median overall survival (OS) of 13 months, and 33.9% were still alive after 18 months, compared with 10.3 months and 24.7% in patients who received chemotherapy alone. Durvalumab is FDA-approved for NSCLC.
In an update also announced at the WCLC, patients with previously untreated metastatic NSCLC who had STK11 or KEAP1 mutations did not respond as well to therapy as patients who lacked the mutations. In the phase III MYSTIC trial, patients were treated with durvalumab, durvalumab plus tremelimumab, or chemotherapy. Across treatment arms, patients with STK11 mutations had a median OS of 6.8 months compared with 12.6 months in patients with a wild-type gene, and those with KEAP1 mutations had a median OS of 7.4 months, compared with 12.9 months in patients with a wild-type gene.
The European Commission approved the PD-L1 inhibitor atezolizumab (Tecentriq; Roche/Genentech) plus chemotherapy in patients with metastatic nonsquamous NSCLC who do not have EGFR or ALK mutations, and in patients with newly diagnosed, extensive-stage SCLC. The approvals were based on the phase III IMpower130 and IMpower133 trials, in which the combination significantly extended OS and progression-free survival compared with chemotherapy alone.
BioNTech filed to raise $100 million in an initial public offering. The move comes after the company raised $270 million in initial funding plus $325 million in private financing. BioNTech plans to use the funding to develop three off-the-shelf shared-antigen immunotherapies in clinical trials in advanced melanoma, head and neck cancer, and triple-negative breast cancer. The company’s lead candidate is the individualized neoantigen vaccine BNT122.
Tocagen announced that Toca 511 & Toca FC may not be effective in patients with recurrent high-grade glioma. In the phase III Toca 5 trial, the therapy did not extend OS compared with standard treatment. Toca 511 & Toca FC is a two-part therapy that uses a retroviral vector to deliver high concentrations of chemotherapy to the brain.
The NCI awarded $28.7 million to the Mayo Clinic Cancer Center in Rochester, MN, and renewed the center’s designation as a comprehensive cancer center following its review, which happens every 5 years. Mayo, which treats more than 120,000 patients annually, is one of 51 NCI-designated comprehensive cancer centers and is the only such center with multiple sites—it also has locations in Phoenix, AZ, and Jacksonville, FL.