Let the jousting begin.
The big abstract drop ahead of ASCO — the annual Olympics of cancer R&D — provided some early, quick snapshots that helped drive stocks up or down, or simply provided a chance to tout some potential in a hotly contested field.
As more and more biopharma money has been invested in the oncology field in recent years, ASCO has been attracting a bigger range of entrants, and abstract night will help determine who comes out on top during the melee ahead. I’ve picked out a few of the most noticeable abstracts, which you can see below.
Loxo takes another round in its bruising, toe-to-toe fight with Blueprint
Loxo Oncology $LOXO was the big winner Wednesday night as investors began to pick through a pile of ASCO abstracts to see what gems could be culled from the numbers.
The biotech’s stock soared 18% overnight as investors spotlighted a 69% overall response rate among 32 evaluable RET-fusion positive patients taking LOXO-292. Loxo’s claim to fame is that it develops cancer drugs that target small, genetically defined patient groups with an agnostic approach to tumor types. Regulators at the FDA have been enthusiastic about this emerging field, which bodes well for Loxo. And they backed that enthusiasm up with data demonstrating a 65% response rate in NSCLC and 83% for papillary thyroid cancer. 84% (27/32) of the patients had radiographic tumor reduction ranging from 19% to 67%.
That’s good, but it may well get better. Loxo CEO Josh Bilenker has flagged that since the January cutoff date for the abstract the data are even better now, which we’ll see at ASCO. Loxo helped stoke the enthusiasm with a note highlighting that LOXO-292 has been selected for best of show at ASCO, which will keep the company in the spotlight.
Cancer R&D, though, is the ultimate blood sport in biotech. And when something goes up, it’s often at the expense of a rival. In this case, that’s Blueprint Medicines — again — which has already felt the sting of a negative comparison with Loxo.
Blueprint Medicines $BPMC has been advancing BLU-667, which has been attracting warm reviews by analysts — unless they start comparing it to the rival. That side-by-side comparison knocked their stock back at AACR, and it did it again last night as the numbers once again favored Loxo. Shares are down about 8% in pre-market trading Thursday.
Novartis vs Gilead/Kite: Is Kymriah better and safer than Yescarta?
Few rivalries have been as intense as the showdown between these two pioneers in the CAR-T field. Novartis’ Kymriah $NVS still has to overcome a nagging issue with one-time manufacturing issues, but Gilead’s Yescarta $GILD is now being compared with its rival, and at first blush may have some explaining to do.
A group in Beijing ran a small comparison study of the two types of CAR-Ts — which use the 4-1BB and CD28 co-stimulatory signaling domains — for CD19-positive B-cell acute lymphoblastic leukemia and found that the Kymriah/4-1BB approach appears to have a distinct set of advantages.
In that 4-1BB arm there was a 100% overall objective response rate, compared to 89% in the CD28 arm. In addition, and more importantly, all 5 of the patients suffering from serious Grade 3 or 4 cytokine release syndrome were in the CD28/Yescarta group. This argument has a long way to run, and Gilead won’t concede an inch of the race. But the comparisons have just begun.
On Monday, Gilead contacted us to offer this statement:
It is important to note that Yescarta was not evaluated in this study. The abstract discusses data from a study evaluating other CAR T products using 4-1BB and CD28 co-stimulatory signaling domains, respectively. Importantly,
Yescarta is engineered using Kite’s manufacturing process. The CD28 CAR T evaluated in this trial was not manufactured by Kite and there have been no head-to-head studies of Yescarta compared to tisagenlecleucel.
Evercore ISI analyst Umer Raffat this morning called the results of this study provocative, but wants to see the details. So do I.
Jounce shares plunge on the latest data cut for JTX-2011
The biggest loser overnight was Jounce Therapeutics $JNCE, which took a nasty hit after posting their update on their lead therapy — JTX-2011. As a monotherapy, 1 out of 7 patients with gastric cancer responded, compared to 2 out of 19 who got the combo with Opdivo — an 11% response rate. The rate wasn’t much better in triple-negative breast cancer.
In a release, researchers hit the theme that these were heavily pretreated patients, but onlookers were in a cantankerous mood and didn’t like the underwhelming numbers. Shares plunged 26% and Wells Fargo downgraded the stock.
Celgene struck a major deal to collaborate with Jounce on this drug, and that wasn’t ignored this morning.
Another thing I’ll say about this is I’ve seen $CELG BD head talk about this Jounce deal at a conference and how to them this was special and they threw so much money at because it is “targeted, biomarker driven etc” development. You have to wonder if Celgene has any clue.
— Brad Loncar (@bradloncar) May 17, 2018
“The preliminary data from patients across multiple solid tumor types enrolled in the ICONIC trial show that JTX-2011 is well-tolerated alone and in combination with nivolumab and has demonstrated evidence of biologic activity and tumor reductions in heavily pre-treated patients who have failed all available therapies. In addition, a potential surrogate biomarker of response has been identified that may help to guide JTX-2011 development,” said Elizabeth Trehu, chief medical officer of Jounce Therapeutics.
Nektar sees a big erosion in response rates for closely-watched I/O star NKTR-214
Nektar $NKTR scored one of the biggest deals in biopharma so far this year when Bristol-Myers came in with a $3.6 billion deal to partner on NKTR-214. That partnership was announced in the wake of the first glimpse of how effective a pairing of their drug could be with Opdivo, with 63% of a small group of advanced melanoma patients responding to first-line therapy. But in Nektar’s update this week researchers note that the response rate in the basket study showed a reduced melanoma impact, with a 52% response rate.
Renal cell carcinoma also dropped, falling to 54%, down from 71% reported in the company’s Q4 call in early March.
That’s by no means the kiss of death. Response rates tend to decline over time. But analysts will be watching these numbers closely to see just how far they drop for a drug that is now front and center in the late-stage oncology pipeline. The stock is down 3% in pre-market trading, with the jury still out on this promising therapy.
Merck KGaA plans to shine a light on its cancer pipeline at ASCO — with Pfizer jumping in
Merck KGaA will be back at ASCO looking to earn some respect for its cancer drug pipeline. So far the bulk of the attention has gone to Bavencio, its PD-L1 checkpoint inhibitor partnered with Pfizer, which is fighting an uphill battle to gain market share against the leaders in the field. But the German Merck has a pipeline in oncology, and they will do their best to highlight their chances on a range of therapies in Chicago.
Its c-Met receptor tyrosine kinase inhibitor tepotinib has earned some kudos from Bernstein. And researchers posted data on 15 patients with advanced non-small cell lung cancer harboring MET exon 14 skipping mutations, with 60% demonstrating a confirmed partial response. Analysts believe this drug could hit $650 million in sales by 2030 — not a blockbuster but a solid success, which the company badly needs after a long drought in clinical development successes.
On the combo front, where all the PD-1/PD-L1 players are focusing on in a variety of ways, Merck KGaA touted their M7824, a TGF-ß trap/anti-PD-L1 bi-functional immunotherapy fusion protein. High PD-L1 expressing patients exhibited an ORR of 71.4%.
The next big step on Bavencio lies in combo therapies, and there Merck KGaA says it gained some early-stage evidence to back up a combination of the checkpoint with lorlatinib in non-small cell lung cancer — a key competitive front for these players. And their combo came out way ahead in the JAVELIN Lung 101 study, which compared their checkpoint with Xalkori (crizotinib) and the lorlatinib match-up. Lorlatinib — a drug Pfizer has high hopes for — came out way ahead. From the abstract:
The confirmed objective response rate with A+C in ALK− pts was 16.7% (95% CI, 2.1-48.4; partial response [PR] in 2 pts), and with A+L in ALK+ pts was 46.4% (95% CI, 27.5-66.1; PR in 12 pts; complete response in 1 pt).
Image: Poster session at ASCO 2017. ASCO
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