Esmo 2020 preview – late-breaking immunotherapy

The upcoming virtual Esmo congress gives top billing to big pharma immunotherapies.

Most of the presentation titles for the upcoming Esmo congress have now been made available, and judging by the late-breaking abstracts the meeting looks to be another one with a heavy focus on big pharma and immunotherapy.

Among the late-breakers two tumour types stand out as a particular focus: front-line gastric cancer, where Merck & Co and Bristol Myers Squibb square off again, and triple-negative breast cancer, which will be of interest to followers of Roche and Immunomedics. In common with other medical meetings Esmo will take place in virtual format.

The congress starts on September 19, and those keen on analysing the data submitted will still have to wait a while. The texts of late-breaking presentations will not go live until two embargo lifts, at 6:05pm Eastern next Thursday and Friday (12:05am central European time on Friday and Saturday respectively). However, the titles at least give a good idea what to look for.

Gastric/oesophageal and gastroesophageal junction cancer is a focus of a presidential session on Monday September 21, where no fewer than four late-breaking studies are being profiled, concerning Keytruda and Opdivo in either first-line or adjuvant settings.

Keytruda is the only anti-PD-(L)1 MAb to have gastric/gastroesophageal junction cancer on its label, but only third line. Last month Bristol said Opdivo became the first such drug to show a first-line survival benefit, courtesy of the Checkmate-649 study, but a week later Keytruda scored in Keynote-590.

Both trials feature at Esmo, and will allow an interesting comparison as Merck and Bristol chase the front-line market.

Selected Esmo 2020 late-breaking presentations
Project Company Abstract Setting Study Presentation
Opdivo Bristol Myers Squibb LBA6 1L gastric/GEJ cancer, chemo combo Checkmate-649 Prez symp 21 Sep
Opdivo BMS/Ono LBA7 1L gastric/GEJ cancer, chemo combo (Japan) Attraction-04 Prez symp 21 Sep
Keytruda Merck & Co LBA8 1L oesophageal cancer, chemo combo Keynote-590 Prez symp 21 Sep
Opdivo Bristol Myers Squibb LBA9 Oesophageal/GEJ cancer (adjuvant) Checkmate-577 Prez symp 21 Sep
Libtayo Sanofi/Regeneron LBA52 1L ≥50% PD-L1 NSCLC, vs chemo Empower-Lung-1 2:37pm 21 Sep
Lorbrena Pfizer LBA2 1L Alk+ NSCLC, vs Xalkori Crown Prez symp 19 Sep
Spartalizumab Novartis LBA43 1L Braf+ melanoma, + Tafinlar+Mekinist Combi-I (failed) 4:20pm 19 Sep
Ipatasertib Roche LBA4 mCRPC, abiraterone combo vs placebo Ipatential-150 Prez symp 20 Sep
Tecentriq Roche LBA11 Neoadj TNBC, chemo combo Impassion-031 12:30pm 20 Sep
Tecentriq Roche LBA15 1L TNBC, chemo combo Impassion-131 (failed) 4:20pm 19 Sep
Trodelvy Immunomedics LBA17 ≥3L TBNC confirmatory vs chemo Ascent 5:04pm 19 Sep
Tecentriq Roche LBA31 1L ovarian, Avastin combo vs Avastin Imagyn-050 4:20pm 21 Sep
Tisotumab vedotin Seattle Genetics LBA32 2/3L cervical cancer Innovatv-204 5:04pm 21 Sep
Keytruda Merck & Co LBA23 1L urothelial, chemo combo Keynote-361 (failed) 4:20pm 19 Sep
Balstilimab +/- zalifrelimab Agenus LBA34 Cervical cancer, anti-PD-1/anti-CTLA-4 combo NCT03894215 ?
Source: Esmo & company announcements. Presentation times are in central European time.

In TNBC, meanwhile, Roche’s Tecentriq will star in the Impassion-031 neoadjuvant study, toplined as positive in PD-L1-positive patients and all-comers alike.

Of course, Tecentriq already has a front-line TNBC label, in ≥1% PD-L1 expressers on the basis of the Abraxane-combo Impassion-130 study. The Esmo post-mortem of the failed Impassion-131 trial will be of interest to those wanting to understand why the Abraxane combo worked while non-encapsulated paclitaxel did not.

It is interesting that Impassion-131 is being highlighted in a late-breaker. Two other failed trials, Keytruda’s Keynote-361 in urothelial cancer and Novartis’s Combi-I study of spartalizumab plus Tafinlar and Mekinist in Braf-positive melanoma, similarly feature in late-breaking presentations, presumably as Esmo continues trying to counter excessively positive data reporting.

Biotech

Biotech investors will also keenly follow the presentation of Immunomedics’ Ascent trial in late-line TNBC, on the basis of which Trodelvy was approved in super-quick time. That late-breaker is being presented on Saturday afternoon.

Other biotech-relevant late-breakers include Seattle Genetics’ tisotumab vedotin, which scored in June in late-line cervical cancer with a 24% remission rate. Investors will try to gauge whether this is enough for regulatory filings, and will be keen to tease out the benefit specifically in third-line patients.

And Agenus has apparently been the beneficiary of an unexpected late-breaker, featuring its own take on the PD-1/CTLA-4 combo of balstilimab plus zalifrelimab. The group comes extremely late to the game here, and its combo is being tested in cervical cancer, where Keytruda monotherapy is already available.

A 'prepping for Esmo' discussion with healthcare specialist and biotech investor Brad Loncar is free to listen to here.

The Esmo 2020 congress takes place in virtual format on September 19-21.

A story on presentations beyond late-breakers has been published separately.

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