Drugmakers Set for Multiple Myeloma Showdown at Hematology Event

(Bloomberg) -- The medical and investment communities will come together to see the latest in treating diseases of the blood including cancer, sickle-cell disease and hemophilia when the American Society of Hematology, or ASH, four-day annual meeting kicks off Saturday in San Diego.

Initial results from a late-breaking abstract ahead of the meeting for AbbVie Inc.’s Imbruvica as a first-line of treatment in chronic lymphocytic leukemia have done little to revive shares, despite what Leerink analyst Geoffrey Porges called “remarkable efficacy” that looks better than the current standard of care. Johnson & Johnson and Genmab will also present promising data for Darzalex in multiple myeloma.

BCMA Battlefield

Investors will also be watching for real-world results in patients getting CAR-T treatments as well as the next generation of immunotherapies, particularly those targeting a protein linked to multiple myeloma known as b-cell maturation antigen (BCMA).

Celgene Corp. and Bluebird Bio Inc.’s BB2121 is widely thought to have the lead among BCMA-targeting therapies for previously treated relapsed myeloma. Results seen to date set what Goldman Sachs analyst Salveen Richter called a “high clinical bar.” Other BCMA competitors are close behind, including LCAR-B38M, an asset licensed to J&J by Hong Kong-traded Genscript Biotech Corp., and Amgen Inc.’s AMG-420. Unum Therapeutics Inc. and Seattle Genetics Inc. have also tested ACTR087 in a small number of patients.

Here are notable companies due to present data. Schedules are in local San Diego time.

AbbVie

  • AbbVie’s Imbruvica in combination with Rituxan showing superior progression-free survival in elderly CLL patients will be highlighted during plenary session at 2 p.m. Sunday

Allogene

  • Updates to Allogene’s pipeline at the meeting will include UCART19 program with Servier, a BCMA CAR T therapy known as ALLO-715, and another CAR-T therapy known as ALLO-819

Amgen

  • Oral presentation of results from AMG 420, a Bi-specific T-cell engager (BiTE) antibody construct, inducing Minimal Residual Disease (MRD) negative complete responses in relapsed multiple myeloma on Monday at 6:30 p.m.
    • Leerink’s Porges expects added results in the five out of six patients who responded at the higher dose
  • Investor meeting webcast Monday at 8 p.m.

Bluebird Bio

  • Bluebird has lost about a third of its value so far this year but analysts including Goldman and SunTrust are telling clients to buy the biotech ahead of ASH results as well as three potential new drug approvals next year
  • Results in myeloma, sickle cell and beta-thalassemia could move shares 20 percent in either direction, William Blair’s Raju Prasad said
  • Initial early-stage results from next-generation anti-BCMA CAR T therapy with Celgene on Sunday at 4:45 p.m.
  • Investor meeting on Monday, Dec. 3 at 8:30 p.m.
  • Presenting multiple Lentiglobin posters on Saturday

Celgene

  • For Celgene “updates to both commercial stage assets and pipeline assets could be stock moving,” shares may benefit on results that continue to support the use of Revlimid-containing regimens as a first-line myeloma treatment, and by answering competitive questions on bb2121, Leerink’s Porges wrote
  • Results from the Phase 3 “Medalist” study of Acceleron Pharma-partnered luspatercept in patients with myelodysplastic syndrome (MDS) to be highlighted during ASH plenary session Sunday at 2 p.m.
  • Data from “Believe” trial of luspatercept in adult beta-thalassemia on Saturday at 2 p.m.
  • Findings from Phase 1/2 “Transcend CLL-004” study of liso-cel (formerly JCAR017) in patients with chronic lymphocytic leukemia being presented Sunday, 8:45 a.m.
  • On Sunday, Celgene to host an Analyst & Investor Event at 8 p.m.

Genmab

  • Late-breaking results released last week from Genmab and J&J’s “Maia” study as a first-line of treatment for elderly myeloma patients are likely to support FDA approval of Darzalex as a front-line treatment and result in relatively rapid uptake of this regimen in the U.S., Jefferies said.
  • Citi said that while bears may point to competitive threats from BCMA and CAR-T therapies, Darzalex is likely to be the “dance/combination partner of choice.” Investors will want to see if the combo gets rid of every myeloma cancer cell (minimal residual disease negative rates).
    • Late breakers are being presented Tuesday starting at 7:30 a.m.
  • Genmab to hold R&D update Monday at 8 p.m. in San Diego

Global Blood Therapeutics

  • Oral presentation for Part A of Phase 3 “Hope” study and data from the 1500 milligram cohort of the “Hope-Kids 1” study with voxelotor on Monday starting at 7 a.m.
  • These results as well as an update on progress of talks with the FDA over potential approval of voxelotor in sickle-cell disease could move shares up or down as much as 50 percent, William Blair said
  • GBT to host investor event webcast Monday at noon local time

Incyte

  • Incyte is presenting detailed “Reach1” study results for Jakafi in graft-versus-host disease on Monday, presentations start at 7 a.m. “Data to shape investor views of approval chances, market potential,” Leerink’s Andrew Berens wrote.
  • Reach1 results were the basis for Incyte’s application with the FDA under priority review for Jakafi as a treatment for acute GVHD.

Johnson & Johnson

  • Aside from Maia results, J&J also has an oral presentation of Phase 1 results of LCAR-B38M in relapsed multiple myeloma on Monday at 4:30 p.m.

Seattle Genetics

  • Seattle Genetics will present results for its “Echelon-2” study, which was the basis for the recent FDA approval of Adcetris as a front-line treatment of peripheral T-cell lymphoma (PTCL)
    • That approval may have been one of the FDA’s fastest turnaround times ever for a review, according to William Blair’s Andy Hsieh; “the magnitude of benefit will likely drive significant and rapid uptake” in the $400 million mature T-cell lymphoma market in the U.S.
  • Oral presentation is Monday at 6:15 p.m.

Swedish Orphan Biovitrum

  • Sobi to present late-breaker Phase 2/3 results for Gamifant

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