Novartis targeted therapy snippet

Discussion with Novartis about the Dabrafenib/Trametinib combo - as we suspected you dont really need to keep the Trametinib in the fridge - they will be re-issuing advice to corroborate this shortly ...

Next targeted therapy combo Cobimetinib plus Vemurafenib

Combimetinib plus Vemurafenib versus Vemurafenib alone

Copy number of BRAF not relevant for response
13% patients had additional mutations at the beginning BUT it has no effect on response.

and no surprise- combo works better than mono therapy! 

T-Vec plus Pembro phase 1b

Update on Phase 1b study

We've been waiting for this one .

T-Vec alone wasn't convincing in the past but this is the combination with Pembro.


Treatment naive patients, 20% Braf pos

Flat dose 200 mg Pembro Q2W used

Side effects typical for immune therapy

Well-tolerated

Unfortunately NO COMMENT on response rates!!!! 

Next step: will be tested in a Phase 3 trial

Sunday Melanoma Session at ECC2015- Nivo then Ipi versus Ipi then Nivo in Stage 4 Melanoma

Update on CHECKMATE 064- Hodi

Phase 2 , Nivo post Ipi vs Ipi post Nivo in Melanoma

140 patients

Ipi 3 mg
Nivo 3 mg

1 prior therapy allowed but no Immuno.



Disease progression more in Ipi first

More side effects on Nivo first

Immune- related side effects
Similar to direct combo

50 vs 31% Hepatitis Nivo/ Ipi vs Ipi/ Nivo


ORR 41 vs 20 % confirmed ORR 

TUMOUR BURDEN REDUCES FASTER on Nivo first

So- conclusion : Nivo then Ipi higher response rate than Ipi then Nivo but more side effects, similar to what one sees when Ipi and Nivo are giving at the same time.

Caroline Robert commented- surprising as currently one thought that Ipi recruits  T-cells that are then activated by PD1.
Also good as it could allow to start with PD1 and only add Ipi when needed, avoiding to limit side effects

Ipi plus Nivo better Nivo/Ipi better than Ipi/ Nivo

To be tested 
Intra-tumoral injection of Ipi plus Pd1

Is innovation affordable? 

Efforts are put in finding new ways of making affordable drugs.  Innovations comes with effective and safe technologies  but cost is making them prohibitive in many parts of the world. During afternoon session an appeal was lunched to get affordable care for everyone who need it.

When resources are highly constraint data collection, early detection, access surgery, x-ray imagining, radiotherapy and access to the basic anti-cancer drugs are seen as priorities. Increasing the means of education and training for the healthcare professionals would make easier the access to the sophisticates techniques and equipments.

On the other hand, to assure at least the access to the essential drugs is a good solution for other cancers, but not helping when comes about melanoma, where chemotherapy is ineffective.  A very good approach to have access to the innovation seems to be running smarter and cheaper clinical trials which would lower the price and make the medicines available earlier for the patients with advanced melanoma and... of course more likely to pass the HTA and to be reimbursed.

Vital Options Advocacy in Action

Interesting discussion from WHO Essential Medicines list, to Global Access issues and what Advocacy organisations need to be doing -

most of all Collaborate between disease areas to be all to put pressure on HTA and Reimbursement Authorities

Come up with plans of action to find strategies to put pressure on Regulators and Pharma to talk/negotiate

Get credible data from patients to force access issues to be taken seriously

Who decides what is an essential medicine and patient advocates need to be deeply involved in this area.

If we think access issues are bad in Europe wait until you see the access issues in sub-saharan Africa and India

Collaboration and Transparency.

ONE more sleep!

The European Cancer Congress in Vienna will start tomorrow!

We will be blogging about interesting findings here. You will also find us on twitter- if you subscribe to  https://twitter.com/MPNEurope/lists/mpneatecc2015 - you will capture all our tweets- and we will obviously post on the MPNE facebook forum.

Safe travel for everyone who's joining us in person, looking forward to seeing you in REAL!

Bettina