Reading our newsletter will keep you up to date with last month’s news items on oncology drug development!

NEWS AND PUBLICATIONS

QUICK TAKE VIDEO SUMMARY

Novel approach for acute graft-versus-host disease prophylaxis
The T-cell transmembrane receptor dipeptidyl peptidase 4 (DPP-4; CD26) has a costimulatory function in activating T cells. While its role was in graft-versus-host disease (GVHD) has been investigated in mouse models, effects of its inhibition in humans are not known. Farag et al conducted a Phase 2 clinical trial to test the effects of the CD26 inhibitor sitagaliptin, combined with tacrolimus and sirolimus, on the incidence of grade II-IV acute GVHD in patients receiving peripheral blood stem cell transplants. Acute GVHD occurred in 2 of 36 patients by Day 100; the incidence of grade II-IV GVHD was 5% and the incidence of grade III or IV GVHD was 3%. At 1-year, non-relapse mortality was zero and relapse-free survival was 46%. The results, published in the New England Journal of Medicine, highlighted the ability of the CD26 inhibitor sitagliptin to reduce the incidence of grade II-IV GVHD by Day 100 of hematopoietic stem cell transplantation.

INDUSTRY

  • Eli Lilly will collaborate with Merus on research and development of up to three early experimental cancer drugs. Under the terms of this collaboration, Eli Lilly will pay Merus an upfront cash payment of $40 million and an equity investment of $20 million in common shares. Merus is also eligible to receive as much as $540 million per product for reaching development and commercial goals. 
  • Hologic acquires Biotheranostics, a leader in molecular tests for breast and metastatic cancers, for approximately $230 million. Biotheranostics’ tests are polymerase chain reaction-based gene expression tests extensively validated in large oncology studies in areas of oncology with critical unmet needs and high growth potential. The acquisition is expected to be slightly dilutive to Hologic’s earnings per share in 2021, break-even in 2022, and accretive thereafter. 
  • Sanofi agreed to acquire Kymab, a human monoclonal antibody developer, in a $1.45 billion deal to gain experimental medicines for inflammation disease as well as cancer. Under the terms of the transaction, Sanofi will pay $1.1 billion upfront and up to $350 million upon achievement of certain milestones. 
  • Genmab achieves milestone in collaboration with AbbVie, worthwhile $40 million. The milestone was triggered by the progress made in the Phase 3 trial of epcoritamab in diffuse large B-cell lymphoma. 

EMA

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

New medicines:

  • COVID-19 vaccine (ChAdOx1-S, recombinant; AstraZeneca) for prevention of coronavirus disease 2019 (COVID-19) in people aged 18 years and older.
  • Selinexor (Nexpovio, Karyopharm Europe) for treatment of relapsed and refractory multiple myeloma. 
  • Pemigatinib (Pemazyre, Incyte Biosciences Distribution) for second-line treatment of advanced or metastatic cholangiosarcoma characterized by fusion or rearrangements of fibroblast growth factor receptor 2. 

Generics/Biosimilars:

  • Bevacizumab (Alymsys from Mabxience Research and Oyavas from STADA Arznemittel) for treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. 
  • Thiotepa (Thiotepa Riemser, Riemser Pharma) as conditioning treatment before hematopoietic progenitor cell transplantation. 

Extensions of indications:

  • Pembrolizumab (Keytruda, Merck Sharp & Dohme) as monotherapy, for the treatment of adult and pediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT is not a treatment option. 

FDA

The FDA granted approval for:

  • Nivolumab and cabozantinib (Opdivo, BMS and Cabometyx, Exelixis) as first-line treatment for patients with advanced renal cell carcinoma. Approval was based on the CHECKMATE-9ER Phase 3 trial, which reported a significant improvement in progression-free survival (PFS) and overall survival (OS) in patients treated with nivolumab plus cabozantinib vs sunitinib alone (16.6 vs 8.3 months and, respectively, not reached in either arm). 
  • Daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech) received accelerated approval in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain amyloidosis. Approval was based on the ANDROMEDA Phase 3 trial, which reported a hematologic complete response rate of 42.1% vs 13.5% in patients treated with Darzalex Faspro vs bortezomib, cyclophosphamide, and dexamethasone. 
  • Crizotinib (Xalcori, Pfizer) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. Approval was based on the ADVL0912 Phase 1/2 trial, which reported an objective response rate (ORR) of 88% and a complete remission rate of 81% in patients treated with crizotinib. 
  • Fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Approval was based on the DESTINY-Gastric01 Phase 2 trial, which reported an OS and ORR of 12.5 vs 8.4 months and 40.5% vs 11.3%, respectively, in patients treated with Enhertu vs irinotecan/paclitaxel.

The FDA also granted breakthrough therapy designation to the following compound to help boost its development:

  • Tiragolumab (Roche), in combination with atezolizumab, for treatment of PD-L1-high metastatic non-small cell lung cancer. 

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