High Points and Hurdles: Immunotherapy Moves Forward

Anita T. Shaffer @Shaffer1
Published: Wednesday, Jun 27, 2012
The company reported that revenue from Provenge was approximately $82 million during the first three months of 2012, representing a 6.5% increase over the prior quarter, and that the number of locations where the vaccine was administered to patients had risen. Previously, Dendreon reported that Provenge generated $261.5 million in revenue from the time of the FDA approval in April 2010 through the end of 2011.4

While tens of millions in sales might be a success story for many products, the costs of producing the vaccine have proved daunting and Dendreon continues to lose money. Sipuleucel-T is custom-made from antigenpresenting cells harvested from the patient through the process of leukapheresis, then cultured to activate immunogenicity, and infused into the patient. The treatment course consists of three intravenous infusions.

Dendreon executives said in the conference call that they are working to reduce the costs of producing Provenge and that they anticipate further improvements as the year unfolds.

Meanwhile, the company’s experiences affect the sector.

“Every time Dendreon sneezed, the rest of the cancer immunotherapy field caught a cold,” said Becker. “If Dendreon is having a good day, many of the other cancer immunotherapy company stocks also go up, and conversely, they go down when Dendreon goes down.”

Although he said investors are starting to differentiate between immunotherapy companies, they are waiting for more evidence that novel immunotherapies are viable clinically and commercially. (Becker’s clients include Bavarian Nordic, which is developing the PROSTVAC vaccine that would, if approved, compete with Provenge).

“We’ve seen, through our interactions with investors, that many of them are saying, ‘You know what, I’m holding off until I see at least one more success story in the field before I put money to work in cancer immunotherapy,’” said Becker. “Investors are just saying, ‘Give me just one more reason to be hopeful that there’s value in cancer immunotherapy.’”

Becker believes that success story could be a positive later-stage clinical trial, a major pharmaceutical company acquiring an immunotherapy license from a developmental company, a notable merger or acquisition in the field, or improved sales of Provenge.

He does, however, feel that advances in immunotherapy— with more products making it to patients— are inevitable.

Dr. Leonard G. Gomella

Leonard G. Gomella, MD

The Bernard W. Godwin Jr Professor of Prostate Cancer, Chairman, Department of Urology, Director, Clinical Affairs, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA

Leonard G. Gomella, MD, has conducted extensive research into the use of immunotherapy in patients with prostate cancer, particularly with sipuleucel-T, for which he was among the principal investigators in the trial that led to its approval.

Earlier this year, Gomella presented an updated analysis of clinical trial data for sipuleucel-T, indicating that the survival advantage for patients treated with the vaccine likely was far greater than the 4.1-month benefit reported in the pivotal trial that led to its approval. The advantage increased because so many patients in the control arm responded after crossing over to a cryopreserved form of the vaccine.5

Gomella remains enthusiastic not only about the future prospects for sipuleucel-T but also about immune- based strategies to treat prostate cancer.

“We did come over a hurdle about 10 years ago in prostate cancer, realizing from a molecular standpoint and from a proteomic and immunologic standpoint that you could stimulate the immune system to recognize prostate cells or turn on the immune system in order to fight advanced prostate cancer,” said Gomella.

During the 5th Annual Interdisciplinary Prostate Cancer Congress (IPCC) in New York City in March, Gomella outlined four distinct approaches to immunotherapy that show promise for clinical advancement in prostate cancer. These are:

  • Sipuleucel-T—A vaccine using dendritic cells through the leukapheresis process
  • PROSTVAC—A vaccine that employs pox viral vectors to stimulate the immune system
  • Ipilimumab—A monoclonal antibody that uses a checkpoint blockade strategy to maintain activated tumor-specific T-cells by neutralizing CTLA4, a coinhibitory receptor
  • 177Lu-J591 —A radiolabeled monoclonal antibody that binds to prostate-specific membrane antigens, which are expressed on virtually all prostate cancer cells, and triggers antibody-dependent cell-mediated cytotoxicity
With such a bounty of new technologies, Gomella said a prime consideration will be how to integrate immunotherapies into treatment timelines.

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