Biotech Strategy Blog

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

Posts tagged ‘atezolizumab’

Can TMB help select patients for lung cancer therapy or not?

Chicago!

One of the key topics arising out of probably the hottest session (lung cancer clinical trials plenary) at AACR last week was tumour mutation burden (TMB).

An important question to be addressed was whether or not the nivolumab plus ipilimumab combination from the CheckMate–227 study will be useful in previously untreated non-small cell lung cancer (NSCLC) patients with a high TMB?

There are a number of questions that occurred to us that need careful consideration:

  • Is TMB ready for prime time?
  • What are the challenges and issues involved?
  • How useful are the data from CheckMate–227 and CheckMate–568?
  • Where are we going next?

To find out more, we had some fascination discussions at AACR with two up and coming young researchers from industry (Dr David Fabrizio of Foundation Medicine) and academia (Dr Nicky McGranahan from UCL in London), who are both experts intimately involved in measuring TMB.

What did they had to say and what does it all mean?

Their candid answers may well surprise a few people…

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AACR18 Red and Green Flags in 1L NSCLC

Chicago: It’s been a crazy busy day here at BSB, with embargoes, key data, thought leader interviews around town, the poster hall and plenty other things to think about.

What I wanted to do here was take a step back after the dramatic 1L NSCLC session and pull together some pros and cons that oncologists will be thinking about going forward.

There’s a lot going on in this market that is worthy of further discussion and debate…

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The path to success in 1L NSCLC

Things are heating up rapidly in the 1L non-small cell lung cancer (NSCLC) space with the latest news that Merck’s pembrolizumab beat out chemotherapy as monotherapy in previously untreated stage 4 patients in KEYNOTE-042.

Is the path to success is a rocky road for some companies in 1L NSCLC?

BMS’s trial in this setting, CheckMate-026, previously failed to show any benefit for nivolumab over chemotherapy, so what gives?

There is no doubt that Merck have been on a roll in lung cancer of late with nary a false step with pembrolizumab thus far.  Is that down to luck or careful preparation?  Are there differences in the molecules or trial designs?

Here, we take a look at the two situations and continue our ongoing analysis as these results certainly offer a ‘tale of two cities’ perspective in the same indication.

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How will the RCC landscape change – who dares, wins?!

For what seems the longest time, we have seen the battle in metastatic clear cell renal cell carcinoma (ccRCC) being focused on various anti-VEGF TKIs, whether against interferon, mTOR inhibitors, and even each other.

Lately, anti-PD(L)1 antibodies have also come on the scene – both as monotherapy and in different combinations – so are things set to change?

Will it be plaining sailing or are there hidden dangers ahead for the unwary?

Here, we take a look at the ever evolving landscape in RCC and explore the issues and challenges surrounding some of the novel combination readouts, including a look at the role immuno-oncology might play going forward.

Not surprisingly, there’s a lot to consider, discuss and think about…

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The death of PD-L1 in urothelial cancer

Prof Tom Powles GU18 Title SlideAt the 2018 ASCO Genitourinary Cancer Symposium, one of the standout keynote lectures was from Professor Tom Powles, Director of the Bart’s Cancer Cancer Center in London who talked about “Immune checkpoint inhibitors in Urothelial Cancer: which one and why?”

We’ve been following the highs and lows around checkpoint inhibitors in bladder cancer for some time, so it was interesting to hear what Prof Powles had to say in San Francisco.

How does he see the landscape evolving for immune checkpoint inhibitors?

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ASCO GI18 Preview

San Francisco

The first cancer conference of 2018 is now upon us and after enjoying last year’s event in San Francisco, I wanted to take some time to explore some key abstracts of interest at the ASCO GI meeting, which begins tomorrow.

This conference covers various updates on new developments in oesophageal, gastric, colon, pancreatic and colorectal cancers.

Are there any trials or new developments to get excited about at this year’s GI18 meeting?

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Tears Before Bedtime…

After writing about the 1L NSCLC landscape every quarter last year, I was thinking the other day that we were due another update and discussion on this riveting topic again soon and added it to the editorial calendar of topics to write about on BSB.

It was therefore no surprise to hear Merck’s announcement this morning that their phase 3 trial KEYNOTE-189 exploring pembrolizumab plus chemotherapy hit its co-primary endpoints and is now the second study to do so after Genentech/Roche’s announcement for atezolizumab plus chemo plus the VEGF inhibitor, bevacizumab was a success.

Are we at a crossroad for lung cancer?  With many more readouts yet to come competition in this space is certainly heating up dramatically!

Meanwhile, there are a few important implications to consider here, so we sat down and penned an update based on the emerging data and highlight some key insights to consider…

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A potential new IO combination for clinical development

A short, but quite important, post today highlighting an early target we are keen to follow in terms of combination trials in both GI and GU cancers, as well as others.

There’s been a lot of focus this year on the so-called inflamed (hot) and non-inflamed (cold) tumours, but what about the intermediate ones that many refer to as the immune excluded phenotype?

View of Geneva from Cathedral St Pierre, Switzerland

Clearly it makes sense to consider different combination approaches in each category, but what would be appropriate? Before we can set about doing that, we first have to uncover the mechanisms causing the inhibition on the tumour microenvironment and then figure out how best to identify those patients most likely to benefit.

Over the last couple of years, we’ve seen and written a lot about various potential candidates (not all will be useful), including myeloid derived suppressor cells (MDSCs), regulatory T cells (Tregs), tumour associated macrophages (TAMs), chemokines, cytokines, adenosine fog and many others.

There is one target that has started gathering a little bit steam over the last year that we have mentioned a couple of times on BSB and now there is something new to discuss here, at least from a big picture perspective.

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IMpower150 lung cancer trial provides a window to the Future of Immunotherapy

Geneva: At the ESMO IO 2017 conference underway in Geneva, the data of the meeting is the IMpower150 phase 3 trial data that will be presented later today by Dr Martin Reck (Grosshandsdorf).

Genentech/Roche have announced a press release ahead of the presentation (Link).

This is the first phase 3 lung cancer immunotherapy trial that combines a VEGF inhibitor (bevacizumab/Avastin), along with a PD-L1 checkpoint inhibitor (atezolizumab/Tecentriq) together with chemotherapy (carboplatin plus paclitaxel).

While we’ve not seen the actual data curves yet, we spoke to Dr Dan Chen (Genentech) about what we can expect to see later today in Geneva, and importantly, we also discussed the significance of the findings from the IMpower150 study.

As Dr Chen told BSB, “this trial is a lot of firsts.”

If you have an interest in lung cancer or immunotherapy, do follow #ESMOImmuno17 on Twitter, as this is data could potentially be practice changing and have a major impact on the lung cancer treatment landscape.

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SCLC – An in-depth look at ROVA-T and TRINITY

Yesterday in part 1 (Link) of our latest mini-series, we looked at the SCLC landscape and some of the key background issues to think about.

This time around in part 2 we drill down focus more specifically on Rova-T, including physician and patient sentiments and in particular, what to watch out for with the upcoming phase 2 TRINITY readout.   There’s a lot to consider here so we’ve broken the analysis down to five key areas.

Mystic Meg is also back with her canny predictions – what does the crystal ball portend for Rova-T and the TRINITY trial?  Caveat: she’s been on a tear of late; this situation will not continue forever.

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