Elahere (mirvetuximab soravtansine What's happening re trial UK?

[win_56]

Ovacome team please can you advise where the U K are are re the elahere trials for platinum resistant patients. It appears to be approved in the U S this year but UK have not heard anything ? Thank you.

[Irisisme]

Hi win_56,

I am about to start a Phase 1b trial with this drug at University College Hospital London. I received the paperwork this morning and haven’t read it all yet.

Iris

[win_56 in reply to Irisisme]

Wishing you all the best.x

[Irisisme]

I just checked on the NICE website:-

To appraise the clinical and cost-effectiveness of Mirvetuximab soravtansine within its marketing authorisation ovarian cancer, peritoneal cancer, or fallopian tube cancer

Topic is suspended

Status Suspended

Decision Selected

Process TA

ID number 1527

So it is not available on NHS

[win_56 in reply to Irisisme]

Are you having trial on NHS? How can NICE make decisions when only in phase 1 trial, doesn't make sense!?

Ovacome admin comments please.

[OvacomeSupport Partner My Ovacome Team]

Good afternoon win_56

Thank you for your question.

Mivertuximab soravtansine is not currently approved for the treatment of ovarian cancer here in the UK. Two phase 3 clinical trials have been investigating this drug:

- SORAYA – Study completion date was November 2022. More details available through this link: classic.clinicaltrials.gov/... .

The results of this trial, which was a non-randomised trial, meant that manufacturers, ImmunoGen, could apply for treatment approval with the FDA in the US which was given accelerated approval at the end of last year. You can find more information about this decision on the FDA website: fda.gov/drugs/resources-inf... .

- MIRASOL – Active, not currently recruiting. Study completion date estimated as April 2024. More details available through this link: classic.clinicaltrials.gov/... .

This trial is now running, which is a randomised trial and fully enrolled. ImmunoGen are hoping for enough data to apply by the end of the year to the European Medicines Agency and then to NICE (National Institute for Health and Care Excellence) for treatment approval. NICE outline their timelines here: nice.org.uk/about/what-we-d... .

Alongside this, there is a phase 1b trial currently recruiting which is ‘designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum resistant ovarian cancer.’ Perhaps this is the trial that Iris mentions above. More details can be found here: clinicaltrials.gov/study/NC... .

More general information about clinical trials can be found here in our clinical trials booklet: ovacome.org.uk/clinical-tri... . Cancer Research UK also provide guidance about clinical trials here on their website: cancerresearchuk.org/about-... . Anyone who is interested in participating in a clinical trial should be able to access personalised advice from their oncologist or a member of their clinical team. The Ovacome support team are here to help anyone to plan or prepare for these conversations, so if there is anyone reading who would find this helpful, please do contact us.

I hope this information is useful. If there's any further information we can provide or anything we may be able to support with, please don't hesitate to get in touch with us. You can reply directly through this forum, email [e-mail] or call our Freephone support line on 0800 008 7054. We're here Monday - Friday, 10am - 5pm.

Best wishes

Annie – Ovacome Support

[Irisisme in reply to OvacomeSupport]

Yes, I am being considered for, and considering, the 1b SL - 172154 with MIRV trial.

Thank you Ovacome 👍😊

[win_56 in reply to Irisisme]

Iris really hope this trial goes well for you and kicks the beast into touch. X💖

[win_56 in reply to OvacomeSupport]

Thank you so much for your reply. Information has been very informative.