Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘Kyprolis’

After some relatively quiet summer months, we have been deluged with questions and requests this month for commentary on some hot topics of late. This seems like a good time to take stock and reflect on some of most frequent ones sent in.

west-acton-tubeThe original Journal Club post slated for today will appear next week instead.

Here, we address numerous queries on the following five topics readers are interested in:

  • APHINITY trial in HER2+ adjuvant breast cancer
  • Array’s BRAF plus MEK data in metastatic melanoma
  • Kite’s interim ZUMA–1 phase 2 announcement
  • Amgen’s Kyprolis in newly diagnosed multiple myeloma
  • BMS nivolumab data in 1L lung cancer (CheckMate-026)

The last two in particular seem to be causing a lot of hand-wringing!

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Aloha! The Eddie Aikau Big Wave surf contest only happens on Waimea Bay on the North Shore of Oahu in a year when there are 40 ft swells. It’s six years since the last one took place.

Surfing Waimea Bay

Waimea Bay Surfing on Feb 10th 2016

Yesterday, at the last minute the big waves failed to show up as an expected storm took a different track.

In R&D terms this is a bit like a phase 3 trial that was expected to be positive, only at the last minute reads out negative.

Last year was an exceptional year in multiple myeloma with several new approvals. It was a “Grand Cru” year, but there is already another wave on the horizon…

Whether it’s a 40 foot Eddie Aikau wave remains to be seen, just like the bay and weather dictates the waves, clinical trial data and physician experience ultimately drive uptake.

This post continues our in-depth post-ASH analysis and pre-TANDEM coverage, with a look at the new wave in myeloma that’s coming our way.

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The big news yesterday evening was that Amgen’s phase III FOCUS trial in relapsed/refractory multiple myeloma failed to meet its primary endpoint of overall survival (HR=0.975).

Kyprolis logoSuch a marginal hazard ratio (HR) tells us that the risk of death was not reduced by taking carfilzomib over best supportive care.

According to the company:

“The 315-patient, open-label study evaluated single-agent Kyprolis® (carfilzomib) for Injection compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma. Nearly all patients in the control arm received cyclophosphamide. Patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry.”

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The ASCO 2014 annual meeting starts on Friday in Chicago and there’s some interesting Multiple Myeloma (MM) data that we’ll be covering.

This preview outlines which MM data may be noteworthy at ASCO and for those going, I’ve included the session times and locations so you can mark your dance card accordingly. There will be more on the potential commercial implications of the data once they have been presented.

Although ASCO is mainly considered a solid tumour meeting, it has not been without some excellent data on hematologic malignancies over the years.

ASCO will always have a particularly soft spot for me since we launched imatinib (Gleevec) for advanced CML on the Friday of ASCO way back in 2001. Many readers may know that I was in new products at Novartis Oncology and was heavily involved in bringing STI571, as it was originally known, to market and subsequently moved on to the brand team.

Gleevec on cover of Time MagazineThe meeting happened in a blur; on Friday we shipped drug for the first scripts the same day within hours of approval received that morning, flew to the conference, had a packed hall with standing room only for 2,000 people in a CME session in the afternoon, presented the one-year phase 3 IRIS data on the Monday, and received a very nice mention from Dr David Scheinberg (MSK), one of the phase 2 trialists during the Sunday plenary session. All these events occurred only a few days after hitting the front page of TIME magazine. It took quite a few weeks to come down from that incredible high!

When people insist ASCO is a solid tumour meeting, I always smile and remember that isn’t always the case.

Hematologic malignancies can generate excellent data mid year. This year, there is good news to discuss, not in CML, but multiple myeloma (MM) at both ASCO and at the European Hematology Association (EHA) Congress in Milan from June 12-15. There is also some nice CLL data, which I will cover in a separate Preview.

What’s different at ASCO this year?

This year, ASCO promises to offer some rather interesting data on some studies in multiple myeloma that missed the ASH deadline last September. You can’t always predict when a readout will occur, so good data can also abound at ASCO, EHA or the Lugano Lymphoma meeting.

As part of our commitment to continuous improvement, we plan a slightly different approach to the daily coverage for ASCO.

This year, we’ll be posting a live blog each day (for subscribers) where we’ll put quick comments about our impressions of data or our thoughts on what’s generating interest, short audio notes and excerpts of interviews with experts.

Given we’re in a lot of sessions and ASCO is pretty spread out (#BlisterWalk), so the live blog won’t be real-time, but we plan to make frequent updates to it during the day.

Please do check back at the blog for daily for updates and insights as they happen.

To learn more about our second ASCO Preview, which is on multiple myeloma, you can sign in or sign up below.

In today’s post, we discuss multiple myeloma and the proteasome inhibitors (bortezomib, carfilzomib and ixazomib), in particular. One of the ongoing debates concerns the toxicities and how the drugs in this class might differ. Whereas melphalan and the immunomodulatory drugs or IMiDs (lenalidomide, pomalidomide and thalidomide) have both been associated with secondary primary malignancies including AML and MDS, especially in combination, cardiotoxicity has been the main focus of debate for the proteasome inhibitors.

Is this a fair rap though?

We should remember that people with multiple myeloma typically tend to be around age 70. Think of Tom Brokaw, the famous newscaster, who was recently diagnosed with the condition aged 74 and is in the median age range, for example. In general, most people over 65 tend to have an increased incidence of cardiovascular disease and myeloma patients also tend to have a slightly higher risk due to disease factors, so there is a background effect that needs to be taken into account.

We should be mindful of the recent scare with cardiovascular events associated with ponatinib (Iclusig) in relapsed/refractory CML, which led to a temporary suspension from the US market and subsequent re-instation with a narrower license, appeared to unnerve both the FDA and investors alike.

At the American Society of Hematology (ASH) meeting in Decemeber, there were some interesting posters, presentations and debates on the proteasome inhibitors in myeloma that are worthy of further discussion. In addition, I sought some thought leader opinions and curated some of the interactions on this topic to add some colour commentary.

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This year at the American Society of Hematology (ASH) there are over 800 abstracts on multiple myeloma alone. Obviously, one can’t possible do them all justice, but there are a number of important ones that are well worth highlighting, especially given the raft of new products in development, as well as some solid data from existing approved products.

Myeloma has long been dominated by proteasome inhibitors and immunomodulatory (IMiD) agents in combination with prednisone, dexamethasone, melphalan or as a triplet such as RVd, VMP etc. In Europe, melphalan still dominates as part of the base therapy, while in the US, dexamethasone (dex or simply d) is preferred partner since the tolerability is much improved along with a lower risk for secondary primary malignancies (SPMs).

In this detailed preview, the following companies and products are covered:

Companies: Millennium, Celgene, J&J, Amgen, Novartis, GSK, Array, Actelion, Biotest, KaloBio, Curis, Verastem, Karyopharm, Aeterna Zentaris.

Products: Ixazomib, lenalidomide, pomalidomide, carfilzomib, panobinostat, daratumumab, ibrutinib, CC-292, afuresertib, GSK2857916, ARRY-520, ACY-1215, indatuximab ravtansine, CUDC-907, VS-5584, selinexor, LCL161, BYL917, perifosine.

I also discuss some controversial topics such as lack of overall survival in the Revlimid trials and the risk of cardiovascular adverse events with Kyprolis. There are also an exciting raft of new compounds with new targets in various stages of development.

Obviously there will be more to come at the meeting, but for now, there’s plenty to discuss and review ahead of time.

Subscribers and those wishing to read the in-depth review by subscribing can click through the Tinypass box below to sign in or sign up – check it out!

I’m not a great fan of Twitter lists, especially those that imply you are a “Top Cat,” because they can end up being divisive and generate resentment in those not included.

ASH Logo picture credit: Pieter DroppertThat said, without wishing to offend anyone, here’s my initial starting point of those I will be following at the 2012 annual meeting of the American Society of Hematology in Atlanta from December 8 – 11 (#ASH12):

American Society of Hematology

Publications

Patient Advocacy

Companies /Industry Execs

Physicians/Researchers & Institutions

This is not intended to be a definitive list, so I encourage you to watch the #ASH12 Twitter stream for additional people to follow depending on your interests. I have intentionally not included PR folks, investors, journalists who are usually too busy writing their own stuff and exhibitors who just want to tweet their own news. However, if I have missed anyone who has a burning desire to be included, please contact me.

Wifi permitting (always a big IF since many conference venues have not invested sufficiently in infrastructure to cope with demand) I’m hoping there will be a good Twitter conversation in Atlanta.

One of the hot topics this year is Multiple Myeloma, for which there are four “Super Friday” satellite symposia and over 700+ abstracts.

Earlier this year, the FDA approved Onyx’s carfilzomib (Kyprolis) and approval for Celgene’s pomalidomide (Actimid) is expected by year-end.  Several other new agents are on the horizon including Millennium’s new proteasome inhibitor ixazomib/MLN9708 that Dr Sundar Jagannath discussed at the recent Chemotherapy Foundation Symposium in New York. The availability of new treatment options is certainly good news for patients.

I am looking forward to attending the ASH education session on Keeping Pace with Advances in Myeloma. Hope to see you there if you have plans to be in Atlanta next week.

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