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Oncology Highlights - November 2019

Stay informed on the latest news within oncology drug development. Subscribe to our newsletter to keep up to date with last month's science, industry and regulatory oncology highlights.

Enjoy reading! - The SMS-oncology team

News and publications

CRISPR gene editing against cancer: Using clustered regularly interspaced short palindromic repeats (CRISPR), a recently developed gene-editing tool allowing for precision edits within bacterial/human DNA, scientists altered immune cells of patients with various cancers to ensure they recognize and fight the disease. This first US endeavor made use of a highly innovative and complex technique generating New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)-redirected CRISPR-edited (T cell receptor and programmed cell death protein 1 [PD-1]) T cells (NYCE T cells) to be used in an ongoing phase I clinical trial. While the results of the trial are pending, with only 3/18 patients having been infused with NYCE T cells to date, the technique has already sparked ethical debates in the scientific community. It remains to be confirmed whether the benefits outweigh the moral issues associated with permanent DNA changes.

Gilteritinib for R/R FLT3-mutated AML: The response of patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) to standard of care chemotherapy is at best infrequent. In this randomized phase III trial in patients with r/r AML, the novel oral selective FLT3 inhibitor gilteritinib was assessed vs salvage chemotherapy. Gilteritinib vs salvage chemotherapy significantly enhanced median overall survival (9.3 vs 5.6 months, p<0.001), while also increasing the percentages of patients with complete remission (21.1% vs 10.5%) or complete remission with full/partial hematologic recovery (34.0% vs 15.3%). These results, together with the improved safety profile, make gilteritinib a promising therapy for high-risk AML patients. Results were published in the New England Journal of Medicine.

INDUSTRY

  • Amgen enters strategic collaboration with BeiGene to expand its oncology presence in China. Amgen will acquire a 20.5% stake in BeiGene for approx. $2.7 billion in cash. Under the agreement, BeiGene will commercialize Xgeva (denosumab), Kyprolis (carfilzomib), and Blincyto (blinatumomab) in China, with both parties equally sharing profits and losses.
  • Takeda enters collaboration with MD Anderson Cancer Center to accelerate the development of clinical-stage off-the-shelf chimeric antigen receptor (CAR) natural killer (NK)-cell therapy platforms in pivotal trials planned for 2021. Under the license agreement, Takeda will receive exclusive rights to develop/commercialize four programs, including CD19-targeted and B-cell maturation antigen-targeted CAR NK-cell therapies. Financial aspects were not disclosed.  
  • AbbVie signs cancer immunotherapy deal with Harpoon Therapeutics worth up to $2.4 billion, gaining the exclusive option on worldwide license for Harpoon’s B-cell maturation antigen HPN217. AbbVie has an option to select up to four additional targets, and pay Harpoon up to $310 million upfront/target for potential development, regulatory, and commercial milestone payments plus royalties on global sales.
  • Bristol-Myers Squibb completes acquisition of Celgene for the total sum of $74 billion. Under the merger terms, Celgene shareholders will receive for each share 1.00 share of BMS common stock, $50.00 in cash without interest, as well as one tradeable Contingent Value Right entitling the holder to a payment of $9.00 in cash if pre-specified regulatory milestones are achieved.

EMA

The Committee for Medical Products for Human Use (CHMP) adopted a positive opinion (extension of indications) for:

Approvals:

  • Polivy (polatuzumab vedotin, Roche Registration GmbH), a CD79b targeted antibody-drug conjugate (ADC), for treatment of r/r diffuse large B-cell lymphoma in combination with bendamustine and rituximab. Polivy was supported through EMA’s PRIority MEdicines (PRIME) scheme

Extensions of indications:

  • Kadcyla (trastuzumab emtansine, Roche Registration GmbH), as single agent, for adjuvant treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.
  • Revlimid (lenalidomide, Celgene Europe BV), in combination with the anti-CD20 antibody rituximab, for the treatment of adult patients with previously treated follicular lymphoma (grade 1–3a).

FDA

The FDA granted approval/clearance for:

  • Brukinsa (zanubrutinib, BeiGene) capsules, for treatment of adult patients with r/r mantle cell lymphoma who have received at least one prior therapy. This accelerated approval of the first Chinese cancer drug for US patient use was based on clinical trial results showing an 84% response rate (tumor shrinkage) with a median duration of 19.5 months in a difficult-to-treat patient population.
  • Calquence (acalabrutinib, AstraZeneca), for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. Approval was based on two randomized actively-controlled trials, ELEVATE-TN and ASCEND, which showed a significantly longer PFS in patients with previously untreated CLL receiving acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil or with r/r CLL after at least one prior systemic therapy receiving acalabrutinib or investigator’s choice. In both trials, median PFS had not been reached in the acalabrutinib-containing arms.
  • Ziextenzo (pegfilgrastim-bmex, Novartis), a biosimilar that decreases the incidence of infection (as manifested by febrile neutropenia) in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs prone to induce this side effect. This is based on analytical, preclinical, and clinical research, including data from the pivotal three-way trial LA-EP06-104.

The FDA also granted breakthrough therapy/device designation to several products to progress their development. These include:

  • An endoscopic AI system (AI Medical Device, Inc.) that analyzes endoscopy images for diagnosis of gastric, colorectal, and esophageal cancers. The system works by applying neural network algorithms trained with real-world datasets of images of biopsy-proven benign/cancer lesions and normal tissue. The specificity of this system, unique in the field, renders its competitive advantage and superior utility.