Marne Wessner

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ASCO GU: Heads-Up for Biotech Drug Development in Kidney Cancer

Posted by Marne Wessner on Mon,Feb 11, 2013 @ 11:50 PM

Interesting Data for Pharma and Biotech Drug Developers

ASCO GU2 2013 Genitourinary Cancers Symposium for Pharma and Biotech Drug DevelopmentASCO’s second meeting of the year, ASCO GU, is coming up next week, and here is our list of anticipated data releases for renal cell carcinoma.  (Note that full abstracts won’t be available until February 12, so it is impossible to comment on the significance of these results until then.) It looks to be a quiet meeting this year for RCC, according to key opinion leaders, but there are some presentations on the schedule with the potential for interesting data for Pharma and Biotech drug developers.

Additional Data from TIVO-1 Trial of Aveo/Astellas’ Tivozanib

There are several abstracts reporting aspects of the TIVO-1 trial data at this year’s meeting. OS, subgroup analyses, and quality of life data are of high interest, and two additional poster presentations will also address biomarker research and tivozanib efficacy in patients previously treated with Bayer’s Nexavar (sorafenib).

Emerging Immunotherapies

Immunotherapy is an exciting field in RCC. The latest generation of immunomodulating agents includes nivolumab, an anti-PD1 from BMS; and AGS-003, a dentritic cell therapy from Argos—both in Ph III for RCC. These agents each have poster presentations, which will hopefully give early indications about their potential in RCC.

Sequencing and Combinations of Approved Therapies for Kidney Cancer

The hottest issue in RCC therapeutics is the sequencing of the many approved agents on the market, and the positioning of any new ones about to be approved. This is a conundrum for oncologists as well as drug developers seeking to leverage the data to gain market share.

  • Votrient: Additional quality of data from the COMPARZ trial of GSK’s Votrient (pazopanib) vs. Pfizer’s Sutent (sunitinib) in first line RCC will report, likely an update of what was reported at ESMO 2012 last fall.
     
  • Inlyta:  Pfizer announced that the AGILE 1051 trial of Inlyta (axitinib) in first line RCC did not meet its primary endpoint in October 2012, and it looks like we will finally see data from that trial as well as the Ph II dosing trial in first line RCC.
     
  • Avastin combos: The Ph II BEST trial, which compared Roche/Genentech’s Avastin alone and combinations of Avastin, Nexavar, and Torisel, will also report data. In RCC, combinations of currently-approved targeted agents have been unsuccessful historically, so expectations are low for this trial.
     
  • mTOR inhibitors: Finally, a new safety analysis of mTOR inhibitors will be presented, which will hopefully provide oncologists with more information on dealing with the side effects of this class of drugs, which are very different from the tyrosine kinase inhibitors that are commonly used in RCC.

 

Key Presentations of Interest at ASCO GU

  1. Overall survival results from a phase III study of tivozanib hydrochloride versus sorafenib in patients with RCC (Motzer, et al, abstract 350)
     
  2. Subgroup analyses of a phase III trial comparing tivozanib hydrochloride versus sorafenib as initial targeted therapy for patients with mRCC (Hutson, et al, abstract 354)
     
  3. Treatment benefit of tivozanib hydrochloride versus sorafenib on health-related quality of life among patients with advanced/mRCC: Tivo-1 study results (Cella, et al, abstract 355)
     
  4. Axitinib vs. sorafenib as first‑line therapy in patients with mRCC (Hutson, et al, abstract LBA348)
     
  5. Quality of life among patients with RCC treated with pazopanib versus sunitinib in the COMPARZ study (Cella, et al, abstract 346)
     
  6. Axitinib with or without dose titration for first-line mRCC: Unblinded results from a randomized phase II study (Rini et al, abstract LBA349)
     
  7. The BEST trial (E2804): A randomized Ph II study of VEGF, RAF kinase, and mTOR combination targeted therapy with bevacizumab, sorafenib, and temsirolimus in advanced RCC (McDermott et al, abstract 345)
     
  8. Incidence and risk of treatment-related mortality in patients with RCC and non-RCC treated with mTOR inhibitors (Choueiri, et al, abstract 347)
     
  9. Clinical activity and safety of antiPD-1 (BMS-936558) in patients with previously treated mRCC: An updated analysis (McDermott, et al, abstract 351)
     
  10. Prolonged survival with personalized immunotherapy (AGS-003) in combination with sunitinib in unfavorable risk mRCC (Amin, et al, abstract 357)


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Developers, Targeted Therapy, Drug Development, Kidney Cancer, Biotech Consulting, Pharma Launch Planning

ASCO GI Preview - Heads Up for GI Cancer Drug Development

Posted by Marne Wessner on Tue,Jan 15, 2013 @ 08:00 AM

ASCO GI Cancer Drug Development

Abstract titles are up for ASCO GI, and here’s a list of the abstracts we are looking forward to seeing next week.  (Note that full abstracts won’t be available until January 22, so it is impossible to comment on the significance of these results until then.)

Abraxane positive in phase III for pancreatic cancer

The Abraxane study in pancreatic cancer (abstract 67) is likely to be the major news from this year’s meeting. At ESMO in October, KOLs were indicating that the results might be positive, and indeed, Celgene announced in November that this trial met its primary endpoint of overall survival with a statistically significant improvement over gemcitabine alone. Now we will finally see the data. There have been so many notable failed trials in this disease (axitinib and ganitumab, for example) that it’s exciting to finally see something positive!

New biomarker and safety data for Stivarga (regorafenib)

Bayer’s Stivarga was just approved for third line CRC in September 2012, and presentations at this meeting include biomarker and safety data (abstracts 318 and 467). Hopefully the new data will shed light on which patients are most suitable for Stivarga and how oncologists can deal with toxicities.

Ramucirumab data notably absent

We also note that the phase III gastric cancer trial of ramucirumab (VEGF inhibitor, Lilly), which was announced as positive a few months ago, will not be presented. The next opportunity to present the data at an important venue will be at the main ASCO meeting in June.

New GI cancer drugs on the horizon at last

KOLs have been complaining that there hasn’t been anything new in CRC for a long time, but it looks like the tide is finally turning with two new approvals in 2012, and some promising new agents on the horizon. All of these developmental agents could eventually make an impact in standards of care for CRC.

In HCC, there are a few developmental agents with early-phase data that will be presented. Of note is the Pfizer CDK inhibitor, PD-0332991, in HCC. Last month at SABCS, this agent reported very promising phase II efficacy data in ER+ breast cancer, as well as a mild toxicity profile. Efficacy combined with good tolerability could make it an attractive compound in HCC.

 

Key presentations of interest for drug development at ASCO GI

  1. Final results of a randomized phase III study of weekly nab-paclitaxel [Abraxane] plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (Von Hoff, et al, abstract LBA148)
  2. Mutational analysis of biomarker samples from the CORRECT study: Correlating mutation status with clinical response to regorafenib (Jeffers et al, abstract 381)
  3. Time course of regorafenib-associated adverse events in the Ph III CORRECT study (Grothey, et al, abstract 467)
  4. Ph II study of PD-0332991 in advanced HCC (Littman, et al, abstract 321)
  5. Patient-reported outcomes from a phase III multicenter, randomized, double-blind, placebo-controlled trial of gefitinib versus placebo in esophageal cancer progressing after chemotherapy: Cancer Oesophagus Gefitinib  (Dutton, et al, abstract 6)
  6. Ph II study of vismodegib, a hedgehog pathway inhibitor, combined with FOLFOX in patients with advanced GaCa and GEJ: A NY cancer consortium led study (Cohen, et al, abstract 67)
  7. A randomized, double-blind, placebo-controlled trial of trametinib in combination with gemcitabine for untreated metastatic PnCa (Infante, et al, abstract 291)
  8. Ph I/II study of golvantinib in combination with sorafenib in patients with advanced HCC: Ph I results (O’Neil, et al, abstract 294)
  9. Long-term efficacy and pharmacodynamic parameter analysis in pretreated KRAS-mutant mCRC patients treated with RG7160 (GA201), an ADCC-enhanced monoclonal anti-EGFR antibody (Delord, et al, abstract 379)
  10. Second-line therapy of KRAS-mutated mCRC with the MEK inhibitor selumetinib in combination with irinotecan: An AGICC study (Hochster, et al, abstract 380)

 


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Development, Biotech Consulting, Competitive Intelligence, Gastrointestinal Cancer, GI Drug Development

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