Interesting Data for Pharma and Biotech Drug Developers

ASCO’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)