ASCO 2015 Highlights

On February 3, 2021, the FDA accelerated the approval of oral tepotinib (Tepmetko; EMD Serono) for adults with metastatic non–small-cell lung cancer (NSCLC) harboring MET exon 14 (METex14) skipping alterations. This approval is for treatment-naïve patients as well as for patients who have received previous therapy. Tepotinib is the second MET inhibitor approved by the FDA and should be selected for treatment based on the presence of METex14. The FDA has granted tepotinib breakthrough therapy and orphan drug designations.

On December 18, 2020, the FDA approved relugolix (Orgovyx; Myovant Sciences), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of adults with advanced prostate cancer. Relugolix is the first oral androgen-deprivation therapy (ADT) and the first oral GnRH receptor antagonist approved for patients with advanced prostate cancer. The FDA granted relugolix priority review for this indication.

On December 16, 2020, the FDA approved margetuximab-cmkb (Margenza; MacroGenics) in combination with chemotherapy for the treatment of adults with metastatic HER2-positive breast cancer who have received ≥2 previous anti-HER2 regimens, of which at least 1 was for metastatic disease. The application for this approval received a fast-track designation.

On January 14, 2021, the FDA approved crizotinib (Xalkori; Pfizer) for the treatment of young patients aged 1 to 21 years with relapsed or refractory systemic anaplastic large-cell lymphoma (ALCL) and ALK mutation. The safety and efficacy of crizotinib have not been established in older adults with this diagnosis. The FDA granted this application priority review and breakthrough therapy and orphan drug designations. Crizotinib was previously approved for patients with metastatic non–small-cell lung cancer and ALK or ROS1 mutation.

On December 18, 2020, the FDA approved osimertinib (Tagrisso; AstraZeneca) for adjuvant therapy after tumor resection in patients with non–small-cell lung cancer (NSCLC) and EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The FDA approved this application 2 months ahead of the FDA goal date and granted it a breakthrough therapy designation. Osimertinib was previously approved for the first-line treatment of metastatic NSCLC and EGFR exon 19 deletions or exon 21 L858R mutations, and for the treatment of metastatic NSCLC and EGFR T790M mutation after EGFR tyrosine kinase inhibitor therapy.

On December 18, 2020, the FDA approved selinexor (Xpovio; Karyopharm Therapeutics) in combination with bortezomib (Velcade) and dexamethasone for the treatment of adults with multiple myeloma after ≥1 previous therapies. The FDA granted this indication an orphan drug designation.

The use of a screening method followed by a financial toxicity intervention that involves navigators, pharmacists, and financial counselors demonstrated significantly improved quality of life for patients with hematologic malignancies, said lead investigator Thomas Greg Knight, MD, Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Atrium Health, Charlotte, NC, at ASH 2020.

The investigational drug pevonedistat in combination with azacitidine injection (Vidaza) leads to longer event-free survival (EFS) and a higher complete response rate than azacitidine alone in patients with high-risk myelodysplastic syndromes (MDS), according to results from a phase 2, open-label, international clinical trial. The findings were presented by Mikkael A. Sekeres, MD, MS, Director, Leukemia Program, Cleveland Clinic, OH, at ASH 2020.

Results of a phase 1 clinical trial showed that approximately 66% of patients with chronic-phase chronic myeloid leukemia (CML) had a major cytogenetic response (MCyR) to the novel oral BCR-ABL1 tyrosine kinase inhibitor (TKI) vodobatinib, regardless of whether they previously received ponatinib therapy. Jorge E. Cortes, MD, Director, Georgia Cancer Center, Augusta University, presented the results at ASH 2020.

Magrolimab, a first-in-class investigational antibody targeting CD47, showed good efficacy when combined with azacitidine injection (Vidaza) regardless of TP53 mutation in patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to data presented at ASH 2020. The results also showed that this combination did not lead to significant immune-related side effects.