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Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘ESMO 2012 News’

Professor David Ferry presents at ESMO 2012 Press BriefingAt the European Society for Medical Oncology (ESMO) 2012 Congress in Vienna, David Ferry, Professor of Medical Oncology at New Cross Hospital in Wolverhampton, reported the results of the Cancer Oesophagus Gefinitib (COG) study, a UK 450 patient, multicenter, phase III clinical trial that looked at whether gefitinib (Iressa) could improve overall survival in esophageal cancer patients who had progressed after chemotherapy.

This is a disease for which there are no treatments that prolong life in the 2nd or 3rd line setting! Sadly, the trial results were negative; there was no difference in overall survival between the placebo and gefitinib study arms.

The results are shown in the graphic that Professor Ferry presented:

Overall Survival Curves for COG Trial presented at ESMO 2012

Placebo Arm (n=225): Median Overall Survival of 3.6 months

Gefitinib Arm (n=225): Median Overall Survival of 3.73 months

A non-significant difference. The data broken down by performance status shows:

  • PS0 – median OS = 6.03M
  • PS1 – median OS = 3.93M
  • PS2 – median OS = 1.97M

That you might think is the end of the story, just another negative trial, another example of the natural selection that takes place in the development of new cancer treatments.

“Gefitinib in Esophageal Cancer – just the beginning of a spicy story”

was the title given to the presentation by Arnaud D. Roth, MD Chief of Oncosurgery at Geneva University Hospital who discussed Professor Ferry’s paper at ESMO 2012.

There are a subgroup of patients who respond

Dr Roth pointed out that there were a subgroup of patients in the COG trial who responded well to gefitinib and lived longer as a result. In the waterfall plot he presented, you can see the partial response highlighted.

 Dr Roth discusses COG trial at ESMO 2012

Using crizotinib as an example, (it is effective in only 5.5% of NSCLC patients), Dr Roth challenged the audience as to why we couldn’t identify the subset of esophageal cancer patients who might respond well to gefitinib.

He noted that 50-70% of esophageal cancers overexpress EGFR protein, suggesting some basis for using an anti-EGFR agent such as gefitinib.

To define this subset of esophageal patients, “we need to go deeper into the biology of esophageal cancer,” Roth said.

His recommendations:

  • Do not lose too much time at looking for discreet mutations predicting response to gefitinib
  • Analyze the responding subpopulation by genomic profiling and examine if they correspond to a particular subtype
  • Validate findings in relatively small clinical studies

Dr Roth concluded that:

“Better knowledge in molecular biology in this disease might help to select patients who might benefit from anti-EGFR TKI’s”

In summary, while the COG trial showed that gefinitib does not improve overall survival in second or third line treatment of esophageal cancer, there is hope that in the future we may be able to identify those patients who might respond, and live longer as a result.

Mitesh J Borad MD presenting TH-302 data at ESMO 2012At the 2012 Congress of the European Society for Medical Oncology (ESMO 2012) in Vienna,  Mitesh J. Borad MD, Assistant Professor of Medicine at the Mayo Clinic in Scottsdale, AZ presented the results of the TH-CR-404 phase 2 clinical trial that compared the efficacy and safety of TH-302 (Threshold Pharmaceuticals) plus gemicitabine versus gemcitabine alone in patients with untreated advanced pancreatic cancer.

TH-302 is an experimental cancer drug in development that kills cells i.e. is cytotoxic under conditions of low oxygen (hypoxia) found in the microenvironment of cancer tumors. Sally Church, PhD on Pharma Strategy Blog has written about the mechanism of action for TH-302 and the results presented earlier this year at the 2012 annual meeting of the American Association for Cancer Research (AACR).

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The 2012 Congress of the European Society for Medical Oncology in Vienna, Austria from 28 September to 2 October is a meeting I am looking forward to attending.

Last year at the 2011 European Multidisciplinary Cancer Congress (ECCO/ESMO/ESTRO) in Stockholm we saw a lot of new data, including the phase III trial results for the ALSYMPCA trial with radium-223 (Alpharadin) in advanced prostate cancer and the Bolero-2 trial with everolimus (Afinitor) in ER/PR+ HER2- breast cancer.

What can we expect at ESMO 2012 this year? 

As we saw last year, the timing of the meeting provides the opportunity for presentation of data that matured after the early 2012 cut-off for submission to the ASCO annual meeting in June.

The titles of the late breaking abstracts have just been published in the ESMO 2012 searchable program. This offers some insight into what we can expect in the Presidential or Plenary Symposia at the meeting, where major trials and ground-breaking data are typically presented.

Presidential Symposia 1 – Sunday, September 30, 2012

  • LBA1_PR | Phase III study of crizotinib versus pemetrexed or docetaxel chemotherapy in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) (PROFILE 1007)
  • LBA2 | SEARCH: A phase III, randomized, double-blind, placebo-controlled trial of sorafenib plus erlotinib in patients with hepatocellular carcinoma (HCC)
  • LBA3 | Cetuximab in combination with capecitabine and cisplatin as first-line treatment in advanced gastric cancer: Randomized controlled phase III EXPAND study
  • LBA4 | Adjuvant FOLFOX4 with or without cetuximab (CTX) in patients (pts) with resected stage III colon cancer (CC): DFS and OS results and subgroup analyses of the PETACC8 Intergroup Phase III Trial

Presidential Symposia II – Monday, October 1

  • LBA5 | PHARE Trial results comparing 6 to 12 months of trastuzumab in adjuvant early breast cancer
  • LBA6 | HERA TRIAL: 2 years versus 1 year of trastuzumab after adjuvant chemotherapy in women with HER2-positive early breast cancer at 8 years of median follow up
  • LBA7 | Results of a randomised phase III trial (EORTC 62012) of single agent doxorubicin versus doxorubicin plus ifosfamide as first line chemotherapy for patients with advanced or metastatic soft tissue sarcoma: a survival study by the EORTC Soft Tissue and Bone Sarcoma Group.
  • LBA8_PR | Randomized, open label, phase III trial of pazopanib versus sunitinib in first-line treatment of patients with metastatic renal cell carcinoma (mRCC); Results of the COMPARZ trial

ESMO 2012 also has a full program of keynote presentations, educational sessions and scientific symposia, so I expect it to be an interesting meeting. I am particularly looking forward to the poster presentations as, often at oncology/hematology scientific meetings, this is where you find useful insights into future new product development.

The twitter hashtag for the Congress is #ESMO12, so do follow this for conversation about the meeting over the next few weeks as the abstracts become available on Monday, September 17 and companies announce the data they expect to present.

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