What's Hot in Cancer Drug R&D?

Summary

Research and Development in Cancer continues to generate enormous interest within industry and commerce. The identification of new disease pathways, the promise of targeted therapies and ever changing appreciation of the nature of cancers and their treatment keep interest high.

The American Society of Clinical Oncology's annual meeting is the premier event where researchers, industry and investors gather to present and discuss the latest developments. Thousands of research papers, documents and posters are presented.

But what is truly significant? How can you sift the interesting from the commercially important?

That is why a copy of this new 160-page report What's Hot in Cancer Drug R&D? is such a valuable document. Researched and written by Matthew Dennis and Fiona Cowie, editors of respected business publication Cancer Drug News, the study distils the huge volume of information and reports the latest important findings. Background and market information, along with stimulating features on key areas, put current thinking into a real world context.

The report provides a valuable aide memoir for those who attended and a first class and comprehensive review for those who didn't.

Contents

• Introduction
  • The 42nd Annual Meeting of the American Society of C linical O ncology
• Disease Incidence
  • Figure 1. Incidence of cancer worldwide by cancer site - 2002
  • Figure 2. Cancer mortality worldwide by cancer site - 2002
  • Table 1. Global cases of selected cancers - 2002
  • Table 2. Global deaths from selected cancers - 2002
  • Table 3. Global incidence of selected cancers per 100,000 population - 2002
  • Table 4. Global death rate per 100,000 population from selected cancers - 2002
• Current Market Size
  • Figure 3. Global cancer drug sales (including supportive care) in 2005 (US$42 billion)
  • Figure 4. Global cancer sales 2002A-2010E
• Future Treatments
  • Figure 5. Anticancer drugs in clinical development
  • FORECAST OF KEY DRUG LAUNCHES BY 2010
  • Table 5. Key drug launches by 2010
• Breast Cancer
  • Overview
  • Table 6. Abstracts covered in the breast cancer section
  • Updated analysis of MA-17 demonstrates benefit of switching to Femara
  • Better survival seen for patients switched to Pfizer's Aromasin; vitamin D deficiency increases bone loss
  • Five years of Arimidex does not cause osteoporosis in patients with normal B MD
  • IN FOCU S: B one health of patients receiving AIs: are cracks beginning to show?
  • Table 7. Median (range) percentage change in BMD from baseline to one, two and five years
  • Table 8. Percentage change of BMD during 24 months of treatment in patients with low or normal vitamin D levels
  • GSK reports positive new data on T ykerb
  • Data show survival benefit for H erceptin in early-stage disease; serum HER 2/neu change
  • predicts clinical outcome
  • Lilly reveals Phase II results for Alimta in first-line MBC ; studies explore potential role of pharmacogenomics
  • AEterna Z entaris reports positive results from Phase I trial with AN-152 in BC s and gynaecological cancer
  • Xeloda+paclitaxel found to be a safer first-line treatment option for patients with MBC
  • Allos' E faproxyn found to reduce tumour hypoxia and HI F-1-alpha expression in human BC xenografts
  • Antisoma reveals positive Phase I data and new trial plans for R 1550
  • Studies demonstrate value of quantifying gene expression in early-stage BC patients
  • Antigen E xpress' trial results presented
• Haematological Cancer
  • Overview
  • Leukaemia
  • Chronic lymphocytic leukaemia
  • Chronic myelogenous leukaemia
  • Acute myeloid leukaemia
  • Lymphoma
  • Multiple myeloma
  • Others
  • Table 9. Abstracts covered in the haematological cancer section
• Pt Presents New Data Evaluating Talabostat In Cl
  • ZIO PHARM's ZIO -101 shows encouraging signs of clinical activity in patients with leukaemia
  • Dacogen alternate dosing trial enrolment complete
  • BMS reports data from dasatinib study
  • IN FOCU S: C ombining targeted therapies: promising approaches
  • Table 10. First- and second-generation TKIs for cancer treatment
  • Table 11. Combining trastuzumab with lapatinib / HKI-272
  • Interim data reported on MGCD 0103 in haematological cancer
  • Cell G enesys reports long-term follow-up data from Phase I trial of G VAX in C ML
  • Eradication of MRD reported in patients with CL treated with G enasense plus CT
  • Genzyme/Berlex release interim results with C ampath in first-line study of B -CL
  • New study shows almost 90 per cent of G livec patients still alive after five years; Z ometa may
  • improve survival in subset of MM patients
  • Positive interim findings from Quadramet combination study in patients with relapsed MM
  • Revlimid survival data evaluated in previously-treated MM; studied in elderly newly-diagnosed
• Mm Patients And Cl
  • Table 12. Common side effects associated with lenalidomide and dexamethasone treatment
  • Table 13. Thrombotic episodes associated with lenalidomide and dexamethasone treatment
  • Data on Vidaza in various haematological and solid tumour cancers presented
  • Phase I study shows that nilotinib helps patients who fail standard therapy
  • Studies show survival increase when MabThera is used as maintenance therapy; mechanism of
  • resistance becoming clearer
  • Mutations in KIT gene predict relapse in adult patients' CB F AML
  • Data demonstrate potential of Velcade across solid and haematological cancers
  • Table 14. Responses to bortezomib and dexamethasone
  • Bioenvision's E voltra prolongs survival in elderly AML patients with adverse cytogenetics
  • Clinical data on Ascenta's AT-101 presented
  • Humanised anti-CD 20 Ab appears safe and active in NHL in Phase I /II study; new bispecific Abs constructed
  • Merck reports pivotal Phase I b study results of Z olinza in advanced refractory CTCL
• Sg Reports Multiple Objective Responses Observed For Sgn -40 In Patients With Aggressive Nhl
  • Study shows non-inferiority of low-dose thalidomide; survival and TD P data reported
  • Vion presents data on C loretazine in elderly de novo AML
  • Xanthus presents Phase I Xanafide results in secondary AML
  • Alexion reports preclinical results with anti-CD 200 Ab; target found to stop leukaemia tumour growth
  • New data show improved outcomes in certain lymphomas with Z evalin
  • Positive interim results for G loucester's pivotal trial of depsipeptide
  • Long-term follow-up data presented on B iovaxID treatment of FL
• Lung Cancer
  • Overview
  • Table 15. Abstracts covered in the lung cancer section
  • Meta-analysis shows benefits of T axotere regimens in patients with advanced N SCLC
  • Pharmacyclics presents additional data and new analyses from pivotal Phase I SMART trial
  • Sutent shows promise against advanced N SCLC
  • Addition of bortezomib improved survival in front-line advanced LC
  • Data from Xyotax STEL AR trials presented
  • Table 16. Comparison of survival (days) in pre- and postmenopausal women
  • Efficacy results from Phase I LC trial support continued study of concurrent cetuximab+CT
  • Antisoma reports survival advantage for AS1404 in LC
  • Predictor of response to I ressa investigated in first prospective biomarker study
  • Encouraging results of clinical study with G SK's MAGE -A3 ASCI report activity in N SCLC
  • Three studies confirm activity of Abraxane as first-line treatment in N SCLC
  • Updated analysis in second-line treatment LC trial confirms similar survival for Alimta and docetaxel
  • Zometa may improve survival in a subset of LC patients
  • Biomarker data analysis supports benefit of T argretin in subsets of N SCLC patients
  • Idera presents preclinical data on TLR 9 agonists in LC models
  • Cabrellis presents additional clinical data of C alsed in SCLC
  • OSI summarises T arceva data; study suggests promise with combination for LC patients
  • Lucanix Phase I data demonstrate significantly increased survival in N SCLC patients
  • IN FOCU S: E arly trial design for targeted therapies: are we getting it right?
  • Table 17. Objectives of early clinical trials for molecularly-targeted therapies
  • Results of key Phase I studies demonstrate PFS advantage for Z actima in LC
• Genito-Urinary Cancer
  • Overview
  • Prostate cancer
  • Renal cell carcinoma
  • Table 18. Abstracts covered in the genito-urinary cancer section
  • Encouraging interim results from combination trial with G VAX; ipilimumab shows positive
  • data in HR PCA patients
  • New data continue to support clinical development of N ovacea's investigational products
  • Therion reports results of Phase I PRO STVAC-VF trial and formalises plan for NCI -sponsored Phase I study
  • Tykerb helps patients with EG Fr-expressing RC live longer
  • Pfizer's Sutent doubles PFS in MRC when compared to current first-line treatment
  • IN FOCU S: T argeted therapies in RC : is sunitinib the future?
  • Table 19. Targeted therapies that may have an impact on the future treatment of RCC
  • Temsirolimus prolongs survival in advanced RC patients with poor risk features
  • Cytogen presents promising data from combination trials with Quadramet and docetaxel in HR PCA
  • Interim results from Phase I trial with perifosine show a 43 per cent partial response rate
  • Table 20. Responses to perifosine
  • Table 21. Side effects of perifosine treatment
  • Phase I interim analysis shows Acapodene increases B MD in PCA patients on ADT
  • MethylGene reports positive results on MG98
  • Updated O S analysis presented on N exavar Phase II trial; I FN alpha combination shrinks RC s
  • MacroArray presents data on diagnostic test for PIN
  • Preliminary Phase I results of T roVax plus IL -2 reported
  • Preliminary results of C hondroGene's work in blood-based detection of CRC and PCA presented
  • ZymoGenetics reports encouraging IL -21 Phase I b results in MM and RC
• Gynaecological Cancer
  • Overview
  • Cervical cancer
  • Ovarian cancer
  • Table 22. Abstracts covered in the gynaecological cancer section
  • Novel biomarkers identified to predict activity of pertuzumab in OC patients
  • Antisoma's AS1404 shows early promise in OC trial
  • Gardasil prevents potentially precancerous vulvar and vaginal lesions
  • Cervarix found to be highly immunogenic and well tolerated in women over 25
  • Ciphergen reports positive results from multi-centre OC biomarker validation study
  • AEterna Z entaris reports positive results from Phase I trial with AN-152 in BC s and gynaecological cancers
  • Data on Vidaza in various haematological and solid tumour cancers presented
  • Three new key studies highlight antitumoural activity of Y ondelis
• Gas Trointestinal Cancer
  • Overview
  • Colorectal cancer
  • Pancreatic cancer
  • Others
  • Table 23. Abstracts covered in the gastrointestinal cancer section
  • Talabostat achieves stable disease and increases time-to-progression
  • New interim Phase I data suggest the antitumour activity of panitumumab in MCRC
  • Repeated R AIT with 131I-labetuzumab in CRC with liver metastases found to be safe and well tolerated
• Pc Patients Live Longer After Treatment With Mab And Ct
  • OBM reports encouraging new Phase I results with T roVax
  • Phase I study shows that Z olinza stabilises patients with advanced CRC
  • Data presented evaluating E rbitux in combination with CT as first-line treatment; results
  • suggest therapy recruits body's immune system
  • Long-term follow-up of Phase I trial examining imatinib in GI ST
• Mb07133 Well Tolerated In Phase I /Ii Study Of Patients With Unresectable Hc
  • Positive early results achieved in development of genomic test for C prognosis
  • Study of Tykerb in liver cancer shows that responders exhibit rash
  • Trifunctional Ab shows encouraging results in peritoneal carcinomatosis resulting from GI tumours
  • Updated results reported from trial in patients for whom imatinib therapy has failed; Sutent shows promise in
  • children
  • Celator presents positive results from Phase I study with C PX-1
  • ADVENTR X reports positive C oFactor Phase I results
  • New data demonstrate role of C ampto regimen as first-line treatment of MCRC
  • Cisplatin combination effective for GC
  • Studies evaluating E loxatin-based regimens in gastrointestinal cancers presented
  • Preliminary results of C hondroGene's work in blood-based detection of CRC and PCA presented
  • Avantogen/Innovate highlight progress in the evaluation of R P101 in combination with CT for patients with PC
• Brain Cancer
  • Overview
  • Table 24. Abstracts covered in the brain cancer section
  • Gliadel significantly prolongs six-month survival
  • Positive final results reported from Phase I R eolysin trial
  • ON 01910.Na active in inducing regression of pre-established intracranial tumours in model system
  • Study demonstrates safety of 131I-TM-601 for high-grade glioblastoma
  • Celldex presents EG FrvII vaccine data
  • New data continue to support clinical development of N ovacea's investigational products
• Melanoma /Sarcoma
  • Overview
  • Table 25. Abstracts covered in the melanoma/sarcoma section
  • Antigenics presents Phase I data from trial of O ncophage in melanoma
  • PT presents data evaluating talabostat in MM and osteosarcoma
  • ARIAD presents positive efficacy data on AP23573 in advanced sarcoma trial
  • Interim ipilimumab Phase II results reported in melanoma
  • IN FOCU S: C ancer as a chronic disease: a shift in focus?
  • Table 26. The cost of targeted therapies
  • Three new key studies highlight antitumoural activity of Y ondelis
  • Research uncovers a mechanism of human angiosarcoma drug resistance
  • ZymoGenetics reports encouraging IL -21 Phase I b results in MM and RC
  • ODC reports MM vaccine research results
  • Oxxon's H i-8 MEL therapeutic vaccine demonstrates potential for treatment of advanced melanoma
• Head And Neck Cancer
  • Overview
  • Table 27. Abstracts covered in the head and neck cancer section
  • Three-drug regimen improves survival in advanced H &N cancers
  • Increased survival and high response rates reported for I ntrogen's Advexin p53 therapy
• Oxigene Releases Positive Data Indicating The Therapeutic Potential Of C A4p In Atc
  • Phase I study highlights significant clinical and biologic activity of sorafenib in PTC patients
  • AMG 706 demonstrates promising antitumour activity
  • OSI summarises T arceva data; study suggests promise with combination for LC patients
• General Developments
  • Overview
  • Table 28. Abstracts covered in the general developments section
  • Callisto reports additional Atiprimod data from Phase I trial in advanced cancer patients
  • Promising data from ArQule's Phase I combination trial with ARQ 501 and docetaxel
  • Xanthus presents Symadex Phase I results
  • Adherex presents final ADH -1 Phase I data; antitumour evidence reported
  • Apo2L may halt cancer growth
  • GX15-070 shows biological activity in refractory lymphomas and solid tumours
  • Encouraging Phase I results for XL647 in patients with advanced solid malignancies; XL880 continues to show
  • promise
  • YM155 appears active and is well tolerated in advanced cancers
  • Genetic variations may explain why some childhood cancer survivors later suffer cardiac side effects
  • Novel MAbs to measure plasma levels of 5-FU developed
  • ImClone presents promising Phase I data on two pipeline MAbs
  • MediciNova presents MN-029 Phase I safety and tumour blood flow reduction results in cancer patients
  • New data show enzastaurin's activity across multiple cancer cell lines
  • Phase I interim data show denosumab decreased bone turnover in advanced cancer patients
  • with bone metastases
  • Active Biotech's Anyara Cancer Project Presented
  • Data from CT -2106 trial presented
  • Clinical trial confirms novel EG Fr MAb targets tumours but not normal tissues
  • Data presented on ispinesib and SB-743921
  • Kosan presents clinical results showing antitumour activity of KO S-953, KO S-1022, KO S-862 and KO S-1584
  • Positive interim results emerge from Phase I R eolysin trial
  • Pro-Pharmaceuticals' D avanat abstract published
  • Interim data presented on MGCD 0103 in solid tumours
  • Sunesis' SNS-595 demonstrates clinical activity and tolerability
  • ZIO PHARM presents preliminary ZIO -201 clinical results; ZIO -101 shows activity
  • Clinical data on satraplatin from two PK studies presented
  • Interim results presented on volociximab for kidney cancer, pancreatic cancer and melanoma
  • New test identifies patients who benefit from targeted cancer drugs
  • THERAPIES FOR CANCER-RELATED COMPLICATIONS
  • Overview
  • Table 29. Abstracts covered in the therapies for cancer-related complications section
  • Phase II results support Aloxi dosing in multi-day CT regimens
  • Aranesp data suggest major response after 27/28 weeks of anaemia treatment; potential benefits
  • of iv iron reported
  • Study explores Procrit once every two weeks as initiation treatment for CT -related anaemia
  • Modasomil improves neurobehavioural dysfunction and fatigue in adult patients with brain tumours
• Company Index
• Compound Index