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Cancer Vaccines Edge Towards Success

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Cancer Vaccines Edge Towards Success DrugWatch Cancer vaccines edge towards success ➜ Richard Harrop* and Stuart Naylor* A number of cancer vaccines are now entering the final stage of clinical development. Are vaccines finally on their way to enjoying mainstream success in the oncology arena? ver the past decade, vaccina- cines that have such a safety profile such as renal cancer and melanoma, tion strategies for the treat- may be readily integrated into current yet they offer only modest benefits and O ment of cancer have been standard-of-care regimens, particularly frequently lead to toxic side-effects. investigated with renewed vigour, per- in the first-line setting where combi- In between these two approaches haps catalysed by a greater under- nation strategies prevail over lie cell-based therapies, in which whole standing of tumour immunology and monotherapies. tumour cells or cell extracts are used as the clinical successes achieved with the immunogen. While tumour-specific monoclonal antibody and cytokine- TARGETED VS NON-SPECIFIC immune responses may be induced, based therapies. However, before vac- Cancer immunotherapies can broadly the precise target(s) of the response is cines become fully integrated into the be divided into two categories: not usually known. Furthermore, arsenal of weapons currently used to tumour-specific and highly-targeted immune responses against other com- treat cancer, they must show not only products, for example vaccines or mon tissue antigens may also be efficacy but also safety and limited or antibodies that target a specific induced. Despite the lack of fine no toxicity. Recently, a number of tumour antigen, and therapies which specificity of the immune response cancer vaccines have moved into the modulate the immune system in a induced and the labour involved in the stages of development where clinical non-tumour-specific way. An example production of autologous, cell-based benefits and good safety profiles can of the latter is BCG, which has been therapies, a number of products have be determined convincingly. used for many years in the treatment completed Phase II and Phase III tri- Reports from a number of Phase II of bladder cancer and has been als with promising results. and Phase III studies suggest cancer shown to provide superior benefits The explosion in the identifica- vaccines are not only well-tolerated over chemotherapy regimens in tion of tumour-associated antigens but that they are also meeting clinical patients with a high risk of progres- (TAAs) in multiple cancer types endpoints, ranging from significant sion. While the precise mode of which occurred in the 1990s repre- tumour responses to improvements in action of the treatment is not known, sented a critical phase in the ability to median survival time. Results from it is accepted that it has an effect on apply tumour immunology research to such trials build on a significant body the immune system. the development of immunotherapy of Phase I clinical data which suggest Likewise, the cytokines IL-2 strategies. This discovery enabled the that, in general, this class of thera- (interleukin 2) and IFNa (interferon α) development of targeted treatments peutic is safe and that the attributed have found widespread use in the and allayed some of the safety concerns adverse event rate is low. Cancer vac- treatment of different malignancies, over the deleterious autoimmune First published in issue 145 of Scrip Magazine May 2005. © T&F Informa UK Ltd 2005. Reprinted with permission of PJB Publications *Richard Harrop is director of clinical immunology and Stuart Naylor is vice-president of biological systems at Oxford BioMedica, based in Oxford, UK 28 ■ CANCER WORLD ■ SEPTEMBER-OCTOBER 2005 DrugWatch KAREN KASMAUSKI / CORBIS CONTRASTO KAREN KASMAUSKI A number of studies suggest cancer vaccines are not only well-tolerated but meet clinical endpoints reactions that can result from less enjoyed a renaissance in the treat- (trastuzumab), Mylotarg (gemtuzum- specific approaches. The successful ment of different cancers, and there ab ozogamicin), Zevalin (ibritumomab targeting of specific tumour antigens are currently eight therapeutic anti- tiuxetan), Bexxar (tositumomab), in vivo has been exemplified by the bodies approved by the Food and Erbitux (cetuximab) and Avastin use of monoclonal antibodies. Drug Administration (FDA) for sale (bevacizumab) achieved total sales in Although they failed to live up to their in the US. Campath (alemtuzumab), excess of US$3 billion in 2004. promise in the 1980s, they have since Rituxan (rituximab), Herceptin While the success of monoclonal CANCER WORLD ■ SEPTEMBER-OCTOBER 2005 ■ 29 DrugWatch antibody therapies cannot be denied, established convincingly. However, tive of confirming recent findings so other targeted approaches are now clinical responses including tumour that FDA approval of Provenge may waiting in the wings, including vacci- shrinkage, disease stabilisation and be sought. nation. Unlike monoclonal antibodies, improvements in time-to-disease pro- Other immunotherapies have led which are usually delivered as a bolus gression are being reported in con- to positive results in subsets of treat- infusion, a vaccine’s therapeutic trolled trials. And more importantly, ed patients, for example, antibody potential has to be transduced statistically significant increases in responders in Aphton’s Phase II trial through multiple biological steps patient survival have been detected of Insegia in colorectal cancer within each patient before any clinical (see Table). patients, or in multiple, open-label benefit is realised. This offers both For example, in June 2004, Aphton Phase II studies including CancerVax’ advantages and disadvantages over the Corporation of Philadelphia trials of Canvaxin in melanoma. In more direct effects of infused mono- announced the results of a Phase III the latter study, retrospective analyses clonal antibody therapies. On the pos- trial of Insegia, a synthetic peptide, showed treatment with Canvaxin, itive side, a vaccine-based approach: similar to a portion of the hormone which consists of irradiated cancer • Induces a broad polyclonal cellular Gastrin 17, linked to the diphtheria cell lines, significantly improved sur- and humoral immune response toxin. The study compared Insegia vival of patients with stage IV • Leads to a response of potentially with placebo in patients with melanoma. The median overall sur- greater longevity, requiring fewer advanced pancreatic cancer and vival time of 268 patients with the injections demonstrated a statistically signifi- cancer, who received Canvaxin fol- • Does not require ‘humanisation’ of cant increase in patient survival time; lowing the surgical removal of their the immune response, unlike the use 150 days for patients receiving the tumours, was 42.4 months compared of monoclonal antibody therapies, vaccine compared to 83 days for to 14.3 months for 170 historical con- which are usually of murine origin those on placebo. trol patients who did not receive the • Costs less And in February 2005, Seattle- vaccine. However, success is dependent on based Dendreon announced encour- Furthermore, a Phase IIb study of the induction of a potent and ‘appro- aging results for its immunotherapy Canadian firm Biomira’s BLP25 lipo- priate’ immune response in a patient product Provenge – autologous den- some vaccine, a synthetic MUC1 group that may be immuno-compro- dritic cells loaded ex vivo with a peptide encapsulated in a liposome mised. Furthermore, an efficacious recombinant fusion protein consisting delivery system, has shown encourag- response may take a month or more to of the TAA prostatic acid phosphatase ing improvements in overall survival induce. Despite these drawbacks, a linked to GM-CSF (granulocyte/ in non-small-cell lung cancer diverse array of cancer vaccines has macrophage colony-stimulating fac- (NSCLC) patients – although it did not made the transition from pre-clinical tor). It was reported that treatment quite attain statistical significance – research to clinical development over with Provenge significantly improved and it has been granted fast-track the past 5–10 years. The positive survival in men with asymptomatic, approval by the FDA. results now being observed in the clin- metastatic androgen-independent Another candidate is TroVax, a ic owe much to a greater understand- (hormone-refractory) prostate cancer vaccine based on the TAA 5T4 deliv- ing of the immune system, the timing when compared to placebo. ered by the attenuated vaccinia virus, and method used to deliver the thera- According to the final three-year MVA (modified vaccinia Ankara), peutic antigen(s) and the increased intent-to-treat analysis of the ran- under investigation by Oxford sensitivity of monitoring tools. domised Phase III study, patients BioMedica in the UK. receiving Dendreon’s investigational A recent announcement reported THE MAIN CONTENDERS product showed a 4.5-month interim data from two Phase II clini- Given the time and money required improvement in median survival time cal trials in which TroVax was admin- to take a product from pre-clinical and a more than three-fold increase istered in combination with research to pivotal Phase III clinical in survival after 36 months compared chemotherapy to patients with late- trials, only a small number of cancer to patients receiving placebo. This is stage colorectal cancer. vaccines have to date progressed to now being followed up with a second Immune responses specific to the stage at which efficacy can be Phase
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