Niraparib (Zejula) Nova Study

hope2022

Hello, I started taking Niraparib 2 weeks ago and was feeling very hopeful about this drug. My oncologist called this morning to tell me to stop taking it as a new study
(Nova I believe is the name) just came out saying it did not prolong survival in people without the gene mutation. I will get more information about this when I see my doctor on June 9th. I was just shocked to get this news and trying to make sense of it all. I don't think there are any other options for me right now. Feeling very scared.
Has anyone heard about this?
hope2022

Fearless_Moderator

@hop2022 I have to say I'm shocked at that advice.  I've reached out to the OCC clinical staff for some context that I can share.  How disappointing to many if this is actually the case.  But often times results have been misinterpreted.  

hope2022

Thank you for reaching out. I appreciate any information that can shed some light on this new study. I understood from the 2019 Nova study that this drug had revolutionized OC. How did they get it so wrong. I see a doctor at the BCCA, so I am not sure if this is just a BC decision or all of Canada. I 'm beyond disappointed, but definitely need more information to have a better understanding of this new study.

Fearless_Moderator

@hope2022 I did try to read the literature on the topic and my sense was that there is some confusion between the actual results and his communication of them, with all due respect to your oncologist of course.  Give me a few days to see what I can find out through OCC, and also through my own contacts in the clinical trial community.  It concerns me your post may be creating anxiety in the population who are taking Niraparib; remembering as well if's being taken by gals with different cancers, stages, genetic makeup, treatment histories etc.  So I just hope no one is reading this and at this point interpreting what he's told you as across the board.  Nor should anyone wait on me.  Go straight to your ownn oncologist and share what you've heard and ask what , if anyrhing , the impact might be on ones sell.  

hope2022

Would you mind sending me the literature that you read? I am still waiting on BCCA to confirm the study name and to get the link. My intention was not to create any anxiety, just to see if i could connect with anyone else that heard this information. 

Fearless_Moderator

@hope2022 just scanned a number of articles on Nova in google.  Some seem to imply some new findings from the trial but I found it all rather confusing to read and I'm usually pretty good at interpreting those results.  But if one doctor is responding the way yours has then we do need to know what substance there is to it.  There are many of our community on Niraparib/Zejula and mostly those who are not BRCA positive. So it's wonderful you raised your concern.  Look for more information here in the next few days that should help arm you with the right questions to be asking at your June 9 meeting. 

hope2022

Thank you again for your support. I did hear from OCC and they are looking into it.

LUCY_BC

This subject certainly caught my eye!  I started this drug in January, had my dose lowered in March and halted the drug mid April due to tachycardia.  Just had my first CT scan done since surgery last Sept., and cancer is back in multiple locations (my last chemo was Nov.) I see my oncologist June 8th to go over results and see what the plan will be.  Obviously Niraparib didn’t work for me. 

hope2022

I'm sorry to hear about your distressing situation. I know how stressful appointments can be. Good luck on the 8th. 

hope2022

I'm wondering if there is anyone that is on Niraparib for a recurrence, that has heard about the ENGOT-OV 16/ Nova study recent update ?  I wanted to reach out and see if anyone had received a call from their oncologist regarding this. 

LUCY_BC

There was a mention of new info on Niraparib that would have cause to pull me off of it, if I was on it for a recurrence but this wasn’t my case AND since I was just finding out about my 1st recurrence and had already pulled myself off the drug in April, there was no more talk of it. 
I’ve been looking on-line trying to find this NEW update for Niraparib but can’t find anything.

hope2022

The study isn't published yet as there is still 14% of the data missing. I believe it may come out in the fall sometime. As far as I know doctors are just making their patients aware of this new data. My doctor has given me the option of staying on it or not. When this news came out I had only been taking it for 2 weeks. 

LUCY_BC

@Fearless - Vol Mod
Hi; I was wondering if you’ve rec’d any new information from OCC clinical staff regarding this new study update on Niraparib? 

Thx

hope2022

@Fearless - Vol Mod Hi, the study I was referring to is the ENGOT OV-16 Nova update. It is not complete yet, but is indicating that taking Niraparib for a recurrence may make future chemo less effective. I just started it May 16th. My doctor has left the decision up to me at this point. I watched the OCC forum session on parp inhibitors and a question was asked regarding this new information. The doctors were in agreement that they were not taking any patients off it as the study wasn't powered for OS and they don't know who dropped out and what treatment came after. I am getting a second opinion July 4th from one of the doctors from the forum. I am in Vancouver. Sorry for making this so long, but feeling so torn right now. Would you mind giving me your thoughts ? Thank you

Fearless_Moderator

@LUCY_BC no, I haven't received any more information than I was able to source using google.  I do know OCC is following this and will advise if anything further is received. 

@hope2022 I feel for your anxiety. It's always the worst when your doctor gives you options.  I guess all I can tell you is the approach I take when faced with a decision like the one you will have to make. 

Since we know the data is premature and therefore it may be more effective than the current data is showing I would hate to come off it and then find out that preliminary finding was wrong and now the window to take the drug again was closed to me. So given the option to stop or continue with no strong push either way from your doctor, I'd look at risks first....if the findings said nothing about any danger in taking the drug and it's only the efficacy in question then am I safe to continue. Then  I'd look at side effects that I'm experiencing....are they tolerable or manageable. And finally what are the options if i stop taking the Zejula now?  Are there other options to consider to avoid recurrence OR if we find the drug does perform as intended, can I go back on it at that point in time.  Those are the things I'd be thinking about myself so perhaps they could inform your conversation in July.  Does that help a bit?  

hope2022

@Fearless - Vol Mod Thank you so much for your thoughts. They were very helpful and I appreciate your insight.  According to my doctor, there aren't any other options if I stop taking it, so that is worrisome of course. I always want to be sure, that I am asking all the right questions , so thank you again for the ones you mention. I felt a bit uncomfortable asking for a second opinion, but am really glad I did. 

Luci22

Glad I found this thread today. My mom was also told the same, although she hadn't started the parp yet, but we were disappointed when the oncologist called and advised her of the update to Niraparib not showing much efficacy in her type of cancer (she is non-brca). She was given a choice to try but she didn't fully know what to do and I called many times to ask for more information yet the nurse didn't really know much and the oncologist didn't call me back.  I asked for the report and she told me she would find out and then didn't hear back.  I have found this oncology clinic less responsive lately and it worries me.  My mom is again on wait and see approach, after having a 1st recurrence, a surgery and chemo again.  
If you get any updates I am eager to know more.   @Fearless - Vol Mod Do you know if there are any other providers or experts I can contact in Ontario (GTA) to get more information or support just speaking to someone to have some clarity?  Much appreciated.

hope2022

@Luci22 I'm sorry to hear about your mom's distressing situation. My doctor shared with me the letter from GSK, the drug company. It did not mention the efficacy of niraparib. It showed the OS was a few months less when you took the drug as opposed to the placebo cohort. It says the reason for this is currently unknown and additional efforts are ongoing. The hypothesis is that it may affect future chemo treatments.  I hope you can get more information from the oncology team. 

Luci22

@hope2022 thank you for replying with this information/update and clarifying.  I may have gotten the message wrong in terms of "efficacy" versus OS, as the onc spoke with my mom and she didn't quite understand.  I hope we all can get more information and that they can work on a drug/PARP for women without a gene mutation.  Seems that much the celebrating around PARPs and treatment progress is going towards those with the gene and it is hard when every type isn't included in that. I try to stay hopeful and hope more work is being done to find treatment for all the variations of OC, for the non-brca's out there.  Staying positive is key.  Please keep us updated if you have any more news on Niraparib and there's any change that you hear of.  Thank you, all the best.

hope2022

@Luci22 Hi, I was wondering if your mom is HGS? The initial study results showed the PFS was longer if you carried the braca gene, but still beneficial if you did not. I believe there is an 8 week window to start the parp after chemo. That might be something to keep in mind. Fearless explained it quite well in one of her comments. I'm hopeful that after my July 4th appt. I will have a better understanding of this new data which should help me make a decision to stay on Niraparib or stop it. I will keep you posted. Take care

Luci22

Yes she's HGS, she just has a mutation called Brip1 but it's not the same as brca1/2 and her onc said that the data showed for women with her type of cancer it was not coming out to be as beneficial for women like her.  Her 8 week window has passed, and with the limited communication we've had with them, we just made no decision.  Her usual follow up is in August.   Look forward to your update.  Take care. 

hope2022

@Luci22 After talking with a second doctor at BCCA,  the recommendation was to stay on niraparib at this time. This is the consensus among the doctors at BCCA. It may affect the next chemo because you are going into it with your bloodwork already being compromised by the drug. Like I mentioned before, the study is not yet complete. This is still just the hypothesis, but it makes perfect sense. The doctor did say that individual benefit from trials is impossible to predict.  

Luci22

@hope2022 thank you for your update.  Glad to hear it is working for you and you're able to continue.  I don't know what we will do, I think we are on the wait and see path since she didn't start niraparib by the 8 week point due to the oncologist's suggestion - although it was her choice.  Hopefully she can have it down the road if she recurs.  If you get an update on the final results of the trial please share it here.  Thanks!

hope2022

@Luci22
All the best to you and your Mom. I will update if I hear anything. The parp is certainly something to consider if your mom has a recurrence. Hopefully she won't need it. Take care

hope2022

@Fearless_Moderator I have been on zejula for just 3 months now. I see my ca125 from Friday had increased by 6, so of course I am thinking the worst. 
I will talk with my doctor tomorrow to get her insight into this rise, but i kind of feel like I already know. The first indication of a recurrence in 2020 was the ca 125 going up by 6. Sorry, I am just babbling on. I can' t imagine having chemo again, when I just finished end of March. Feeling so disappointed right now. 

Luci22

@hope2022 I hope you are able to get some answers regarding your ca125.  I have heard that if it rises by a few points it's not the same concern as if it were to rise by many more.  Good luck!

hope2022

@Luci22 Thank you for your post. Still waiting to hear from my doctor. I'm anxious to get some questions answered. I hope your Mom is doing well in her recovery. 

GloHo

For anyone currently researching this drug, I found the following updated articles on the ENGOT-OV16/NOVA study:

Note: This was a study for platinum-sensitive (not platinum-resistant) ovarian cancer.

Targeted Oncology, March 2023
Final Analysis of Niraparib Does Not Show Significant OS Benefit in Recurrent Ovarian Cancer

Mar 27, 2023, Conor Killmurray

BMJ - International Journal of Gynecological Cancer, 2023
Review. Safety and Management of Niraparib Monotherapy in ovarian cancer clinical trials 

Another source would be to check the ClinicalTrials.gov site to see if the results have been posted. I see that the results for this particular study were updated in April 2023. These results are very data-heavy.

Research for PLATINUM-RESISTANT, BRCA-NEGATIVE, ovarian cancer is lacking and I found a few trials that were terminated due to futility. 

Journal of Clinical Oncology, 2022
MOONSTONE/GOG-3032: Interim analysis of a phase 2 study of Niraparib + Dostarlimab in patients (pts) with platinum-resistant ovarian cancer (PROC). Results may be of interest. The study not continued due to futility.

Of interest: California only, not yet recruiting (May 2023)
Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum-Resistant Ovarian Cancer

This is a study listed on ClinicalTrials.gov. The estimated start date is May 2023. The primary completion date is 2025. 

As you can see, for those of us in the platinum-resistant, BRCA-negative, cohort, there is very little research to inform our decision of whether or not to try Niraparib (Zejula) if it is offered to us. I did try Zejula as a maintenance drug immediately following my second successful round of platinum-based chemo. Unfortunately, the drug did not work for me and my cancer recurred within six months, resulting in the platinum-resistant diagnosis. I personally, did not have any severe reaction to the drug, just fatigue, which seems to be the norm for most of us receiving any type of cancer treatment. I have also heard of a few women who have had success with the drug for extended periods of time, with very few/mild side effects.

This is a personal decision after weighing the pros and cons for yourself. Remember that each of us is unique - different types of ovarian cancer, different types of markers, different stages of the disease, etc. And, we all respond differently to the various treatments available. Researching for yourself, followed by a discussion with a medical oncologist would be very beneficial in helping inform your decision. 


Caveat: I did not read all articles. I wanted to update this thread because there is new information and this drug has a few other discussions ongoing. 

jobo

Thanks for posting this, @GloHo.  Kind of depressing news, given the bright early promise of PARP inhibitors.  

GloHo

@jobo

On the bright side. There are success stories out there! You don't really know until you try it for yourself. Like I said, we are all different and react diffently to each treatment. There are a couple of trials (Ontario/Quebec) currently recruiting for Niraparib...so research is ongoing.

Phase 2: Princess Margaret only

Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor

Phase 1/2: Ottawa, Toronto, Montreal

A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer (OPAL)

I was just looking at research in my previous post. I did a quick check for current trials (Ontario) and came up with the two above. 

Fearless_Moderator

@jobo,  Olaparib is still on the table and proven effective albeit for BRCA 1 & 2.  It is a shame Niraparib was marketed as the alternative for those of us non-BRCA though.  It seems there has been much negative publicity about it's intended effectiveness fairly recently.  I know there are several studies ongoing to prove or disprove what's being said about it.    What I haven't heard is anything negative trying it so I tend to agree with Glotto.  We are all different and respond differently to the various drugs available to us.  One can always stop Niraparib if side effects become unmanageable or after a reasonable period of time no positive results (reduction or stabilization) are indicated.  A good conversation with one's oncologist and cancer care team will help with that decision.