Biotech Strategy Blog

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

Posts tagged ‘mirvetuximab soravtansine’

What do cancer drug development and Sherlock Holmes have in common?

The simple answer is that sometimes you can gain insights by looking at what did not happen.

Will belantamab mafadotin stand out in the crowded BCMA space?

In 1892 Sir Arthur Conan Doyle wrote a short story about the disappearance of a famous racehorse the night before a race. What was curious about the incident was that there was no barking from the watchdog when you might otherwise have expected it, suggesting the dog knew the thief…

Can we follow the same inductive reasoning when it comes to cancer drug development? Are there things we would expect to see, but don’t? If so, what inferences can we draw from them?

In this post we’re taking a closer look at the latest data for GSK2857916 (now belantamab mafadotin), which in many ways was “the dog that didn’t bark” at ASH19.

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Chicago – Having stayed until the last morning of the last day for a final expert interview and sessions on CAR-T therapy and metastatic breast cancer, there were certainly some interesting targets and findings to discuss in the post meeting analysis.

I particularly wanted to post some thoughts and commentary on the ongoing Macrogenics story around margetuximab, an anti-HER2 antibody that binds with elevated affinity to both the lower and higher affinity forms of CD16A, an Fc receptor.

In our last review in February, we noted that the company “could miss on PFS and have to wait for OS down the road,” which wasn’t far off given the rather weak PFS benefit of 0.9 months announced on May 15th.

We finally got to see the initial SOPHIA data presented at ASCO this morning by Dr Hope Rugo (UCSF), so what did we learn?

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File under: intriguing binary events coming up of interest this quarter…

Source: BBC

There are a couple of phase 3 readouts likely due soon on two quite different oncology drugs in late stage development, namely Mirv and Marge, (aka mirvetuximab soravtansine and margetuximab).

For British readers, they remind me of Howard and Hilda Hughes (right) in the highly popular 1980’s comedy sitcom, lead by Richard Briers, Ever Decreasing Circles.

Aside from the fact that it’s an amusing historical analogy with more than a bit of whimsy, there are some strange parallels and hidden messages to be found here. For the record, the two characters had a penchance for wearing matching yet rather garish and ghastly jumpers.

You could either make a similar negative case for the rush from limited phase 2 data to pivotal registration study as for terribly ugly sweaters, with the reduced return on efficacy being alluded to from the show’s title.

The ripple effect – which way will it go?

Or on the other hand… the matchy matchy look could also play out the other way, in terms of positive forthcoming readouts validating phase 2 findings, so which case looks stronger overall for each agent?

To find out, we take a look at the history, what we know, and share our thoughts on how things might pan out – either way, major positive or negative outcomes can have a major ripple effect.

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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.

ASCO 2016 Posters 5

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!

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For years we’ve followed the trials and tribulations of targeted therapies seeing many approved and quite a few disappear forlornly (and officially) off to dog drug heaven. Many more sit in no-man’s land as companies eagerly wait in a holding pattern for other trial readouts in different tumour types. Sadly, sometimes these studies don’t generate enough compelling data either. With so much competition about, there are no shortcuts or low-hanging fruit in biotech or cancer drug development any more.

ASCO16 Chicago 1

En route to Chicago and ASCO!

Then along came antibody drug conjugates (ADCs), with some encouraging results in a range of cancers in both solid tumours and hematologic malignancies that lead to the approval of several new therapies.

After that, the next big advance was immunotherapies, specifically checkpoint blockade, with encouraging single agent activity in melanoma, lung, and even urothelial bladder cancer. We’ve also seen the promise fo combining two different checkpoints such as nivolumab and ipilimumab together in metastatic melanoma, albeit with an increase in toxicities.

This is all very well and good, although the challenge remains that the majority of patients either respond to therapy and relapse, or do not respond at all, depending on the circumstances, the tumour type and the regimen. We still have a long way to go in moving the needle and creating a new paradigm shift on a broad scale.

So what happens when we start to combine modalities – such as targeted therapies with immunotherapies?

Uh-oh, I hear the distant cries of disagreement erupt…

  • Remember vemurafenib plus ipilimumab in metastatic melanoma was scuppered by severe hepatitis?
  • What about osimertinib plus durvalumab in NSCLC and the increased incidence of ILD?

Both of these statements are true, and yet… we should not assume that all mixed therapy combination approaches are doomed on the basis of a mere n of 2. What happens if some are synergistic or additive? What happens of there are hidden gems that teach us new ways of doing things rather than doing the same old thing just because it’s always been done that way?

With this in mind, I’d like to open the door on our first ASCO 2016 Preview series with a look at novel combination approaches in development that caught my eye.

What are the early hints and signals that we can learn from the data? Which companies are evaluating imaginative new ideas that may turn the tables on traditional thinking?  The ideas discussed here may well surprise a few people.

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Last month’s Biotech Strategy mailbag – where we answer questions from subscribers – turned out to be rather controversial with strong feelings running in several camps on Puma Biotech’s neratinib in breast cancer.

This time around we have a bunch of questions on completely different topics and compounds to cover:

  • BRAF plus MEK and/or immunotherapy in BRAFV600 metastatic melanoma
  • Immunogen’s IMGN853 – now known as mirvetuximab soravtansine – in platinum resistant ovarian cancer
  • AbbVie/Genentech’s ABT–199/GDC–0199 venetoclax

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