Review Period Extended in GIST, Disappointing Findings in Lung Cancer, and More

Today-

A review period extended in gastrointestinal stromal tumor, disappointing findings in lung cancer, a European application withdrawn in lung cancer, European positive opinions in myeloma and of a biosimilar, and ASCO announces its cancer advance of the year.

Welcome to OncLive News Network! I'm Gina Columbus.

The FDA has extended the Prescription Drug User Fee Act deadline for a new drug application for avapritinib as a treatment for adult patients with fourth-line gastrointestinal stromal tumor.

The deadline, which was initially February 14, 2020, has been extended by 3 months to May 14, 2020.

Previously, the FDA requested topline data from the company's ongoing phase III VOYAGER trial, which is evaluating avapritinib and regorafenib in third- or fourth-line GIST. The data are slated to inform the pending action on the application for the fourth-line setting.

Additionally, BluePrint Medicines, the developer of avapritinib, stated that it plans to provide the topline data to the FDA in the second quarter of 2020, so that the agency will be able to decide on the application by the new deadline.

The company also announced that the National Comprehensive Cancer Network updated its Clinical Practice Guidelines in Oncology for Soft Tissue Sarcoma to include avapritinib as a recommended category 2A treatment for patients with unresectable or metastatic GIST with a PDGFRA exon 18 mutation, which includes PDGPRA D842V mutations, and fourth-line GIST.

In January 2020, the FDA approved avapritinib for the treatment of adult patients with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.

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In non—small cell lung cancer, the addition of dinutuximab injection to irinotecan did not improve overall survival versus irinotecan or topotecan alone in patients with relapsed/refractory small cell lung cancer, missing the primary endpoint of the phase II/III DISTINCT trial.

Dinutuximab is a GD2-binding monoclonal antibody approved for use in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and 13-cis-retinoic acid, as a treatment for pediatric patients with high-risk neuroblastoma who achieve a partial response or greater to prior induction treatment.

The topline data also showed that the safety profile of the combination was consistent with prior studies and the current label for dinutuximab. Full results will be presented at an upcoming medical meeting and will also be included in peer-reviewed publications.

A label expansion for dinutuximab in combination with irinotecan and temozolomide for the treatment of pediatric patients with relapsed/refractory neuroblastoma is also being pursued.

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Bristol-Myers Squibb has withdrawn its application in the European Union for the frontline combination of nivolumab and ipilimumab as a treatment for patients with advanced non—small cell lung cancer.

The application was originally filed in 2018 as a first-line treatment for patients with NSCLC who have tumor mutational burden higher than 10 mutations/megabase, and was based on final progression-free survival findings from the phase III CheckMate-227 trial.

The application was also later amended to include overall survival data from part 1a of CheckMate-227, which compared nivolumab plus ipilimumab with chemotherapy for patients whose tumors expressed PD-L1 greater than 1%.

While the European Medicines Agency’s Committee for Medicinal Products for Human Use recognized the integrity of the patient level data, the committee determined that a full assessment of the application was not possible, following the multiple protocol changes the company had made. There are no plans to refile the application in the European Union.

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The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for the rituximab biosimilar PF-05280586 for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis, and pemphigus vulgaris.

The submission is supported by a comprehensive data package demonstrating biosimilarity with PF-05280586 to reference rituximab, including results from the REFLECTIONS B3281006 study. The trial evaluated the efficacy, safety and immunogenicity, pharmacokinetics, and pharmacodynamics of PF-05280586.

Results showed that there were no clinically meaningful differences in safety or efficacy between the biosimilar and standard rituximab in patients with CD20-positive, low tumor burden follicular lymphoma.

The European Commission is expected to make a decision on the approval in the first half of 2020.

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In multiple myeloma, the European Medicines Agency has validated a Marketing Authorization Application for belantamab mafodotin for the treatment of patients with relapsed/refractory disease whose prior therapy included an immunomodulatory agent, a proteasome inhibitor, and a CD38-directed monoclonal antibody.

The antibody-drug conjugate was accepted for accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use.

The application is based on data from the pivotal DREAMM-2 study, in which belantamab mafodotin demonstrated an overall response rate of 31% with the 2.5-mg/kg dose of belantamab mafodotin in this patient population. In patients who received belantamab mafodotin at 3.4 mg/kg, the ORR was 34%.

The safety data were consistent with previously reported data on belantamab mafodotin.

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Following significant progress made in the development of novel systemic therapies for patients with cancer, the role of surgery in oncology continues to evolve. For this reason, ASCO has selected the refinement of surgical treatment of cancer as its Advance of the Year as part of Clinical Cancer Advances 2020: ASCO’s Annual Report on Progress Against Cancer.

ASCO stated that substantial progress has been made in prior years in the understanding and development of systemic therapies in cancer care. However, the impact of these advancements on surgical care has only come to light recently.

Examples of refined surgical techniques include less-invasive surgery in melanoma due to neoadjuvant immune-based combination therapies, TKIs as an alternative to cytoreductive nephrectomy in kidney cancer, and higher resection rates from neoadjuvant treatment in pancreatic cancer.

ASCO's annual update on advances made with oncology treatments spotlights pivotal clinical research milestones and policy developments that have been made over the past year.

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This week, we sat down Dr Ghassan Abou-Alfa, of Memorial Sloan Kettering Cancer Center, to discuss the results from the phase III IMbrave150 trial.

That's all for today.

Thank you for watching OncLive News Network! I'm Gina Columbus.