Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘trabectedin’

Roche on a roll with positive data for Avastin in ovarian cancer

By on February 25, 2010

After yesterday's news regarding the negative data for bevacizumab (Avastin) in gastric cancer, I wasn't expecting to hear any more from Roche this week, however, the opposite happened and this morning positive data was sitting waiting for me in my inbox today!

What's new?

Well, results from phase III study demonstrated the combination of bevacizumab and chemotherapy followed by maintenance use of bevacizumab increased the time women with advanced ovarian cancer lived without their disease worsening as measured by progression-free survival (PFS) compared to chemotherapy alone. Advanced ovarian cancer generally has a poor prognosis, so new therapy options are much needed.

Roche's press release declared that:

"This is the first positive phase III study of an anti-angiogenic therapy in advanced ovarian cancer and continues to support Avastin and anti-angiogenesis as a fundamental pillar of cancer treatment today."  

What does the data show?

The Gynecologic Oncology Group (GOG) completed a three-arm trial in women with newly diagnosed advanced ovarian cancer who already had surgery to remove as much of the tumour as possible were randomised to receive one of the following: 

  1. Placebo in combination with commonly-used chemotherapy (ie carboplatin (AUC 6 IV) and paclitaxel (175mg/m2) for 6 cycles), followed by placebo for a total treatment duration of up to 15 months. 
  2. Bevacizumab (5mg/kg for 5 cycles starting at cycle 2) in combination with carboplatin and paclitaxel (6 cycles), followed by placebo for a total treatment duration of up to 15 months. 
  3. Bevacizumab in combination with carboplatin and paclitaxel, followed by the continuation of bevacizumab alone as maintenance therapy, for a total treatment duration of up to 15 months. 

Overall, the trial showed that women who continued maintenance use of bevacizumab alone, after receiving bevacizumab in combination with chemotherapy (Arm 3), lived longer without the disease worsening compared to those who received chemotherapy alone.  Women who received bevacizumab in combination with chemotherapy, but did not continue maintenance therapy with bevacizumab (Arm 2), did not live longer without the disease worsening compared to chemotherapy alone.

The full results will be presented at ASCO in June.

Meanwhile this is an interesting development in ovarian cancer, given that J&J have a filing for trabectedin (Yondelis) with the FDA for the same disease, although ODAC expressed concerns about the risk-benefit profile given the side effects associated with the chemotherapy.

Time will tell what will happen later this year but at the moment it's looking more promising for Roche/Genentech than J&J.

When NICE lives up to it's name…

By on December 29, 2009

Lately, we seem to have heard nothing but bad news from across the pond with the National Institute for Clinical Effectiveness (NICE) seemingly rejecting approval for reimbursement of many new cancer drugs, causing an outcry in the physician and patient communities alike.  One such example was the recent rejection of the second generation tyrosine kinase inhibitors (TKIs), dasatinib (Sprycel) and nilotinib (Tasigna) after failure of imatinib (Glivec) in chronic myeloid leukemia (CML).

However, this morning I heard from industry friends that actually, NICE has finally approved something without too much drawn out hassle.

The drug?

PharmaMar/J&J's trabectedin (Yondelis) in soft tissue sarcomas.

Interestingly, the same drug is getting a rather rough ride with the FDA and ODAC in ovarian cancer over here in the US, but anecdotally, I have heard from several oncologists who participated in the EU trials that the drug has a role to play in refractory STS given the lack of choices beyond ifosfamide based regimens.

So, what can we learn from the NICE decision, especially given that J&J also managed to obtain reimbursement for Velcade in the UK?

It is clear that companies not only need to show some pharmacoeconomic benefit, but also offer some discount or incentive for the cash strapped NHS to see a bargain.  J&J made a creative deal whereby they would cover the cost of bortezomib (Velcade) in cases where the drug did not work, so the NHS would only pay for those that did. 

What happened in this case? 

NICE originally issued draft guidance earlier this year not recommending trabectedin
for use on the NHS due to its high cost.  According to the final appraisal document published on Dec 21st, a workable solution had been hammered out:

"Trabectedin is recommended as a treatment option for people with advanced soft tissue sarcoma if:

  • treatment with anthracyclines and ifosfamide has failed or
  • they are intolerant of or have contraindications for treatment with anthracyclines and ifosfamide and
  • the acquisition cost of trabectedin for treatment needed after the fifth cycle is met by the manufacturer."

All in all, that seems a fair enough solution with a win-win for everyone involved.  In 2010, we may well see more sensible approaches like this with some flexibility to work towards compromise on both sides. Drug companies are learning that they can't just charge what they like willy nilly expecting approval based on limited resources and NICE is learning to be creative in seeking effective solutions to increase patient access to new therapies that may make a difference to their daily lives.

Who knows, the US may well gravitate towards the inclusion of cost-effectiveness measures in decision making over the next 2-3 years as well.

Related articles by Zemanta
Reblog this post [with Zemanta]
error: Content is protected !!