World Lung and SITC – two more doses of oncology
With 2017 drawing to a close investors still have at least two oncology-focused conferences to look forward to before Ash kicks off in December. The first of these, the World Conference on Lung Cancer, starts in Yokohama, Japan this weekend.
This will feature the ongoing battle between Loxo and Ignyta in mutated NSCLC, as well as data from a low-key asset Spectrum licensed from Hanmi in 2015. Later, the SITC meeting in November is where Juno will at last reveal findings from Rocket, and investors should look out for an explanation of the neurotoxicity that scuppered this study last year (see tables below).
Both meetings have a strong leaning towards early-stage work, though there are exceptions. The highlight of World Lung’s plenary, for instance, features more data on Imfinzi’s Pacific trial, which at Esmo gave Astrazeneca new hope in lung cancer – specifically in the little-noticed setting of stage III NSCLC.
Biotech investors’ attention will be elsewhere, however. While the terms under which Spectrum had licensed poziotinib from Hanmi were not disclosed, the company had made much of this pan-Her inhibitor’s potential in breast cancer patients who had failed Her2-directed therapies including Herceptin and Tykerb.
At World Lung results from eight platinum-refractory NSCLC patients with exon 20 insertion mutations will be presented. Updates will also come from Chi-Med’s savolitinib and fruquitinib in combination with Tagrisso and Iressa, and from Pharmamar’s ongoing phase III Atlantis trial of Zepsyre in SCLC.
Perhaps the most interest will fall on a battle between Loxo and Ignyta in NSCLC with TRK, Alk and Ros1 fusions – and the potential for a tumour-agnostic indication – that has already played out at several scientific meetings, most recently Asco (Asco – Loxo nudges ahead of Ignyta with tumour-agnostic therapy, June 3, 2017).
Ignyta’s update is from its Startrk-2 study of entrectinib, while Loxo’s falls on LOXO-292, a follow-up to its lead, larotrectinib. Loxo's other follow-on, LOXO-195, has already shown early promise in patients relapsed on larotrectinib, and the World Lung abstract describes an initial response with LOXO-292 in a patient who acquired resistance while being treated with Ignyta’s own follow-on asset, RXDX-105.
|Selected abstracts from the World Conference on Lung Cancer, in Yokohama, Japan, Oct 15-18|
|Project||Lung cancer focus||Company||Study detail||Trial ID|
|Imfinzi||Stage III NSCLC||Astrazeneca||Plenary presentation||NCT02125461|
|Opdivo||Malignant pleural mesothelioma||Bristol-Myers Squibb||Merit study (late breaker)||?|
|Keytruda + chemo||1L NSCLC||Merck & Co||Keynote-021G update||NCT02039674|
|Alunbrig||Xalkori-refractory Alk+ NSCLC||Takeda||Alta study (phase II)||NCT02737501|
|Savolitinib||2nd-line NSCLC||Chi-Med||Combo with Tagrisso (Tatton study)||NCT02143466|
|Fruquitinib||EGFR-mutant NSCLC||Chi-Med||Combo with Iressa||NCT02976116|
|Zepsyre||2nd-line SCLC||Pharmamar||Update from Atlantis trial (due to end recruitiment Q1 2018)||NCT02566993|
|Poziotinib||EGFR Exon 20 mutant NSCLC||Spectrum/Hanmi||8 platinum-refractory pts||NCT03066206|
|Entrectinib||Ros1 NSCLC||Ignyta||Startrk-2 study||NCT02568267|
|LOXO-292||Ret-fusion lung cancers||Loxo||Patients refractory to earlier Trk-directed therapy||NCT03157128|
Meanwhile, late-breakers from the SITC (Society for the Immunotherapy of Cancer) conference are not yet available, and only titles have been published for the meeting’s other abstracts.
However, Evercore ISI’s Umer Raffat reckons Bristol-Myers Squibb has scored an SITC late-breaker covering a dose-escalation trial of its irreversible IDO inhibitor BMS-986205, and Incyte bulls will be keen to see whether this backs up Bristol’s claim to have the best asset in this class, which could hit Incyte’s rival agent epacadostat.
Interest has also been generated by Juno’s decision to present full data from Rocket, an adult ALL trial of JCAR015, which until recently had been its lead CAR-T project. This trial, and the asset, were scrapped after five deaths due to cerebral oedema; the precise mechanism of this sudden adverse event is still unclear, and investors will look to Juno to shed light on the matter.
Cell therapies also feature from the relatively unknown private biotechs TCR2 Therapeutics, Pique and IRX, and an academic group looking at anti-CD3/anti-Her2 “armed activated T cells”. And, in biotech’s continuing search for slightly improved me-too targets, Macrogenics and Aduro will respectively present their anti-PD-1 and anti-CTLA4 MAbs.
SITC is a long-standing meeting that has only relatively recently caught the attention of investors, but in the craze for all things immuno-oncology it can no longer be ignored.
|Selected abstracts from the SITC meeting, National Harbor, MD, Nov 8-12|
|Project||Therapy focus||Company||Data type|
|JCAR015||Adult ALL||Juno||Phase II Rocket trial (NCT02535364)|
|Allogeneic vaccine (PT 107)||2nd-line NSCLC||Pique Therapeutics||Phase II|
|Anti-CD3/anti Her2 activated T cells||Her2- breast cancer||?||Phase II (possibly NCT01022138)|
|IMCgp100||Uveal melanoma||Immunocore||Phase I (NCT02570308)|
|Dendritic cell vaccine||Melanoma||TCR2 Therapeutics||Comparison vs autologous tumour cell vaccines|
|Citoplurikin + TILs||Breast cancer (neoadjuvant)||IRX Therapeutics||Phase I (NCT02950259)|
|Tremelimumab||Urothelial cancer||Astrazeneca||Efficacy & tolerability data|
|CB-839 + Opdivo||Solid tumours||Calithera||Phase I (NCT02771626)|
|MGA012 (anti-PD-1 MAb)||Solid tumours||Macrogenics||Phase I monotherapy (NCT03059823)|
|ADU-1604 (anti-CTLA4 MAb)||Characterization of a "novel differentiated" MAb||Aduro||Preclinical data|