Following the recent approval of Clovis’s rucaparib (Rubraca) by FDA under priority review as monotherapy for the treatment of women with certain types of advanced ovarian cancer, then impressive SOLO-2 maintenance data after initial chemotherapy at SGO earlier this month, PARP inhibitors continue to be in the news.
There’s always more though!
This afternoon saw the approval of Tesaro’s PARP inhibitor niraparib (Zejula) by the US Food and Drug Administration (FDA) for maintenance treatment of women with ovarian cancer who are in a complete or partial response to platinum-based chemotherapy (Link to label).
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The recent PARP inhibitor data has stirred up a lot of interest amongst BSB subscribers (See post: PARP! PARP! what’s hot in ovarian cancer at SGO and AACR?).
So, rather than do another AACR 2017 Preview (more coming next week!), it seemed timely to take a look at some of the interesting questions we’ve received from subscribers.
Five questions have been selected for answer in this week’s BSB reader Q&A. We don’t award prizes if your question is selected, nor do we name who asked the question, but everyone benefits when interesting questions are asked and we can all learn from each other.
As author Thomas Berger aptly said:
“The art and science of asking questions is the source of all knowledge.”
What differentiates many world class cancer researchers is frequently the scientific questions they ask in their work. The same holds true if you are a C level executive or a journalist. The quality of the answer you obtain is often dependent on the quality of the question you ask.
We hope that being better informed about the issues and topics we write about on BSB will enable subscribers to ask better questions, and in the process make better decisions.
Subscribers can login to read more (and see if your question was answered) or you can gain access via the blue box below…
There’s no secret or surprise with our latest AACR Preview as this week the focus takes a slight turns or detour to the annual meeting of the Society for Gynecology Oncology being held in National Harbor, Maryland.
PARP inhibitors in ovarian cancer have been a hot topic since last autumn when the PARP inhibitor data dropped at ESMO in Copenhagen, and was not without controversy either.
We’ve been following the trials, tribulations and even machinations, of the clinical development of olaparib, rucaparib and niraparib for a while now so what’s in store in the latest round of salvoes?
And importantly, what else can we expect to see in DC at AACR next month?
For a tumour type that hasn’t received much attention over the last decade or two, things are distinctly picking up. Is it all good though?
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HI Koko Crater Flowers
Over the last week or so, we’ve received a lot of questions on the following topics relating to women’s cancers in breast and ovarian carcinomas:
- APHINITY impact – pertuzumab and neratinib
- PARPs in ovarian cancer – niraparib, rucaparib and olaparib
- Seattle Genetics and Immunomedics
So this is probably a good time for a February BSB Reader Q&A post on the hot topics of the moment in cancer research.
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Part 3 of our series on Gems from the Poster Halls at ESMO continues with a look at another four important combination studies that may be of keen interest to readers.
These include both targeted therapies as well as immunotherapies.
Some of the posters I was originally keen to write about turned out a little unexpectedly with some issues to address i.e. lack of efficacy or unwanted toxicities based on the dosing schedule used and may require tweaking of the dosing, schedule or trial design. Others will unfortunately be destined for dog drug heaven unless a new tumour type offers more promise. Such is the R&D roller coaster that is oncology – sometimes we forget that more compounds fail than make it market.
The good news is that there were plenty of promising approaches that are worthy of writing up and discussing. In the third part of our poster mini-series, we take another deeper dive with a careful look at some new data in Copenhagen.
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One of the surprising things I learned over the summer was how many people misunderstand how advanced ovarian cancer is treated as a disease… it isn’t really one disease to start with, but is actually a series of subsets depending on the molecular underpinnings and also how women with the condition react to therapy.
Imagine then, when we see a series of press releases and abstracts emerge on PARP inhibitors followed by a rather indecent and sudden rush to judgment by Wall St and investors on the ‘Winner takes All’ out of the lot?
Except that real life doesn’t work that way in clinical practice.
A head/desk moment to be sure, and a frustrating one for those who understand what this is actually all about. To address this siituation, we had the pleasure of communicating with KOLs remotely or sitting down with several thought leaders in gynecologic cancer in Copenhagen to debate various aspects relating to current treatment paradigms, new clinical trial data with PARPs, and what they are most excited about going forward.
Today’s post highlights our latest thought leader interview with an experienced GYN oncologist and their perspectives on the rucaparib and niraparib data presented earlier this month at ESMO.
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Today’s news that an FDA Oncologic Drugs Advisory Committee (ODAC) review will not be required for rucaparib is good news for Clovis Oncology. The company announced this via an SEC 8K filing:
“The Food and Drug Administration (“FDA”) has notified Clovis Oncology, Inc. that FDA is not currently planning to hold an advisory committee meeting to discuss the Company’s New Drug Application for rucaparib.”
However, given the unmet medical need in ovarian cancer, a lot of companies are targeting both platinum sensitive and platinum resistant disease.
In our fourth preview of the forthcoming European Society for Medical Oncology (#ESMO16) meeting we’re looking at 9 key ovarian cancer abstracts to watch out for at ESMO.
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Tesaro’s niraparib is a highly selective poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor that can induce synthetic lethality in tumor cells with homologous recombination DNA repair deficiencies (HRD), including germline BRCA-mutated tumours. It received a lot of attention yesterday following the company’s announcement that the phase 3 trial successfully met its primary endpoint. The trial was expected to readout this month, so it was bang on schedule.
Braving the scrum in the ASCO 2016 poster hall
The results generated a lot of discussion and also a bunch (half a dozen!) of questions from readers, since there was a lot noise around the top-line data in the press release, but very little real analysis or context.
I was planning on rolling out the draft posts we have been working on Gems from the Poster Halls, which included one focused on ovarian cancer. It therefore makes sense to combine the poster analysis with a reader Q&A on ovarian cancer, including a detailed look at Tesaro’s niraparib as there are some important subtleties that many have missed.
Inevitably this ended up as a rather meaty analysis rather than the quick review I originally intended!
To learn more about the latest developments in PARP inhibitors and the ovarian cancer landscape, you can sign-in or sign-up in the box below…
PARP inhibitors have had a chequered history as anti-cancer agents from the lows of the failed iniparib (Sanofi) phase 3 trial in triple negative breast cancer (TNBC) and olaparib (AstraZeneca) in ovarian cancer to the highs of the initial waterfall plots for BMN673 (Biomarin) in BRCA-positive breast and ovarian cancers and a successful graduation from the ISPY2 trial in the triple negative signature for veliparib (AbbVie). In between those two extremes, there has been a lot of uncertainty.
At ASCO this year, there was a decent crop of new combination data in both posters and oral sessions looking at various PARP inhibitors in breast or high grade serous ovarian cancer with either chemotherapy (typically platinum-based) or targeted therapies such as PI3K (BKM120) or VEGF (cediranib).
Another new development, which was hinted at from previous AACR conference notes was the potential to explore Biomarin’s BMN673 in lung cancer, specifically metastatic small-cell lung cancer (SCLC) and germline BRCA-mutation carrier cancer patients in a poster for a phase 1 dose finding trial.
Wainberg et al., concluded that:
“BMN 673 has antitumor activity in patients with advanced previously treated SCLC and significant activity in patients with gBRCA mut ovarian and breast cancer.”
Emphasis the authors.
For today’s article, we’re taking a slightly different approach. Rather than analyse the clinical data, I wanted to explore physician sentiments around PARP inhibitors and they thought about this class of drug. Is there still traction here or has the rise of immuno-oncology wiped out interest in targeted agents?
To find out more about the thought leader sentiments, you can sign in or sign up below: