Asco-GU 2020: revving up for Peloton deal validation

The meeting’s abstracts point to studies from Merck & Co, Exelixis and others that should be on investors’ radar.

Conferences

Last year Merck & Co paid over $1bn to buy Peloton Therapeutics on the back of data that, while very impressive, came from just 55 subjects. An update from this first-in-human study on Saturday should give a better idea whether this was money well spent.

The venue for the presentation will be the Asco Genitourinary Cancers Symposium, which starts in San Francisco tomorrow and continues with presentations into Saturday. Also on the radar are clinical results with Cabometyx, which look to reverse Exelixis’s 2014 failure in prostate cancer, though investors should look for more information on a treatment-related death mentioned in the abstract.

Exelixis’s Cosmic-021 trial combines Cabometyx with Roche’s Tecentriq, and its Asco-GU abstract refers to a very early data cut in castration-resistant prostate cancer subjects who had progressed on novel hormone therapy. This showed a 32% overall remission rate for the combo.

Cosmic-021 aims to enrol 1,732 patients across various cancers, but for now only the uncontrolled combo data are available, so a comparison is tricky. Stifel analysts reckon 8-18% remission rates in Merck’s Keynote-365 study of Keytruda plus Lynparza provides a benchmark of sorts.

Investors will want to know why Cosmic-021 shows promise when in the similar setting of Cosmic-1 Cabometyx failed against prednisone (Exelixis wiped out after Comet-1 crash lands, September 2, 2014). They should also ask about the treatment-related death from dehydration of a 90-year-old Cosmic-021 subject.

Riding in the Peloton

Meanwhile, the Asco-GU abstract for Merck’s MK-6482 relate to a May 2019 cut-off, and were already known at the time of Peloton’s $1.05bn takeout: a 24% ORR in 55 subjects with second-line or later renal cell carcinoma. The presentation on Saturday should provide a more up-to-date dataset.

MK-6482 is claimed to be the first small-molecule inhibitor of HIF-2α, and another closely watched indication for it is von Hippel-Lindau disease. According to EvaluatePharma sellside consensus MK-6482 has yet to be included in most analysts’ models, so more validation of the Peloton takeover is keenly awaited.

Selected Asco-GU 2020 abstracts
Project Company Mechanism Detail Study Abstract
Thursday 13 February
ADXS-PSA Advaxis/Merck & Co Anti-PSA vaccine Keytruda combo in mCRPC Keynote-046 part B 126
Pasotuxizumab Bayer/Amgen (ex Micromet) Anti-PSMA BiTE First-in-human study in mCRPC NCT01723475 124
Talabostat Bioxcel DPP & FAP inhibitor Keytruda combo in mCRPC NCT03910660 140
SHR3680 Jiangsu Hengrui Antiandrogen First-in-human study in mCRPC in China NCT02691975 90
Cabometyx Exelixis TKI Tecentriq combo in mCRPC Cosmic-021 cohort 6 139
Friday 14 February
Padcev Seattle Genetics/Astellas Anti-nectin-4 ADC Keytruda combo in 1L urothelial cancer EV-103 441
Guadecitabine Otsuka (ex Astex) DNMT inhibitor Platinum-refractory germ cell tumors NCT02429466 408
Infigratinib Novartis FGFR inhibitor 3/4 CRs in FGFR3-altered nonmuscle-invasive bladder cancer NCT02657486 510
Saturday 15 February
MK-6482 Merck & Co (ex Peloton) Oral HIF-2α inhibitor First-in-human stdy in ≥2L RCC NCT02974738 611
Sitravatinib Mirati TKI Opdivo combo in 2L RCC NCT03015740 612

Other Asco-GU abstracts that have caught analysts’ eyes include an update on Seattle Genetics’ EV-103 study of Padcev, and Mirati’s sitravatinib plus Opdivo combo in advanced renal cancer.

The latter yielded a 38% ORR, which Leerink said was promising and beat the 20-22% seen with Opdivo or sitravatinib monotherapy in another study. Mirati, of course, is an all-in bet on the Kras inhibitor MRTX849, so sitravatinib could give the sellside reason to raise target prices yet further.

Padcev, Seattle/Astellas’s anti-nectin-4 antibody drug conjugate, secured accelerated US approval in December for anti-PD-(L)1-relapsed urothelial cancer on the basis of the EV-201 trial. EV-103 is a front-line study in combination with Keytruda, and had already impressed at last year’s Esmo meeting.

The Asco-GU abstract relates to a June data cut, with ORR now 73% (71% at Esmo) and a 12.3-month median progression-free survival. Since Tecentriq plus chemo yielded 8.2 months of mPFS in Imvigor-130 the updated data presentation, due on Friday, should make EV-103 one of the highlights of Asco-GU.

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