Lilly Expands Breast Cancer Choices & Novo Signs for Three Obesity Programs

Lilly has a new breast cancer combination approval. Inluriyo plus Verzenio enters after disease progression, adding another treatment choice as competition moves earlier.

And LEO Pharma says its pill for painful light sensitivity has Priority Review. We'll look at what the trial measured, and what more time in sunlight actually means.

Welcome to The Pharma Closeout for Friday, September eighteenth. I'm Alex Mercer.

And I'm Maya Patel. Today, the treatment choices changing now, and the evidence behind the ones still coming.

In our top story, Lilly's Inluriyo plus Verzenio has full FDA approval for advanced or metastatic breast cancer. Inluriyo was already approved on its own. Now Lilly can pair that newer oral medicine with its established Verzenio franchise in an approved, all-oral regimen.

The approval is for adults with ESR1-mutated, estrogen receptor-positive, HER2-negative disease that progressed after at least one endocrine therapy. The FDA also approved Guardant360 CDx to identify eligible patients. In EMBER-3, the FDA highlights an exploratory analysis of 159 patients with the mutation. Median progression-free survival was 11.1 months with the combination, versus 5.5 months with Inluriyo alone. Overall survival was still immature, so a survival benefit hasn't been established.

AstraZeneca just gained an approval in this space, too. Are these regimens competing for the same treatment decision?

They enter at different points. AstraZeneca's Etcamah received accelerated approval with a CDK4/6 inhibitor before progression. It applies when an ESR1 mutation is detected in circulating tumor DNA during first-line treatment with an aromatase inhibitor plus a CDK4/6 inhibitor. Patients must have had at least six months of that treatment, without disease progression. The endocrine drug changes; the inhibitor continues.

That makes the timing of a treatment change part of this competition. Detecting the mutation can now lead to a switch before progression; Lilly's combination enters afterward. Which sequence works best is still open. EMBER-3 didn't compare those strategies or test Etcamah.

Now moving to our Deal and Pipeline roundup, Novo Nordisk signed an asset purchase agreement for three obesity programs from Kallyope. Novo executives Jacob Petersen and Tamara Darsow describe all three as non-incretin programs. They identify K-554 as an IND-ready peptide program, alongside two early small molecules. This is an agreement for programs, rather than an acquisition of Kallyope itself. Closing remains unconfirmed. The price and targets haven't been disclosed.

Separately, Novo signed a discovery and licensing collaboration with Orbis Medicines for oral macrocycles in cardiometabolic disease. Orbis brings its discovery platform to multiple targets. Orbis says the deal could total up to $1.4 billion, combining an undisclosed upfront payment with potential development and commercial milestones. Tiered royalties and a separate Novo strategic investment sit outside that figure.

The intended medicines would be oral, but the deal begins with discovery work. Orbis hasn't named the targets or said how many programs the collaboration will cover.

The Kallyope agreement covers defined programs; Orbis supplies a route to discovering new ones.

On the financing side, Electra Therapeutics said in its pricing release that its upsized IPO would generate about $350 million in gross proceeds. Electra is a late clinical-stage biotech. Its lead antibody, ipsoprubart, is in registrational development for a severe hyperinflammatory disorder. Electra said closing was expected September twenty-first, subject to customary conditions.

Now a pipeline stop at Bristol Myers Squibb. Orum Therapeutics says BMS discontinued the CD33-directed degrader-antibody conjugate that came from Orum, after reviewing Phase 1 data. The program was being developed for acute myeloid leukemia and myelodysplastic syndromes. Fierce reports that BMS paid $100 million upfront in 2023, and ending development removes Orum's chance to earn up to $80 million in clinical-development milestones.

Orum hasn't disclosed why the data led to that decision. We can't label it an efficacy failure or a safety problem.

Turning to Regulatory Watch in Europe, MaaT Pharma says CHMP confirmed its negative opinion on Xervyteg after re-examination. The proposed microbiome therapy targets severe gut complications of acute graft-versus-host disease after transplantation. Patients in the proposed indication have disease that's resisted treatment. MaaT reports that the committee found the single-arm evidence insufficient to establish benefit-risk. Without a randomized comparison, the package left uncertainty the committee wasn't prepared to accept.

Does MaaT have a path to answer that concern?

It has a proposal. PHOENIX would compare the therapy with best available treatment in a randomized Phase 3 study. Funding and regulatory clearance are still required. The unresolved question is whether the benefits outweigh the risks; the negative opinion doesn't establish that the therapy has no benefit.

Next, EMA says its tailored clinical approach to biosimilars has produced its first positive recommendation. CHMP backed Pebrilzo, a biosimilar to Roche's Perjeta for adult breast cancer. Biosimilar Collaborations Ireland is the EMA-listed applicant. The European Commission's decision is still pending.

That changes which studies a developer may need, without changing the requirement to establish biosimilarity.

A dedicated comparative efficacy study may not be required for a well-characterized biologic. That applies when analytical comparison can detect differences more sensitively than a clinical efficacy study would. Pharmacokinetic and appropriate safety studies remain part of the package. Pebrilzo puts that tailored approach into practice, without making it a blanket exemption for other biosimilars.

Finally in European regulation, CHMP backed earlier use of Johnson and Johnson's Tecvayli on its own. The proposed indication covers adults with relapsed or refractory multiple myeloma after at least one prior therapy. The expansion draws on the Phase 3 MajesTEC-9 study. It's separate from the existing daratumumab combination indication. The European Commission still has to decide.

That would broaden where Johnson and Johnson can compete with the standalone regimen in Europe. How far apart would that put the European and U.S. monotherapy labels?

The current FDA label still puts monotherapy after at least four prior lines. The U.S. combination indication after one prior line is a separate matter.

Quick note before our second top story today — if The Pharma Closeout is how you close out your day, follow the show on Spotify or Apple Podcasts.

That second story is LEO Pharma's dersimelagon. LEO says the FDA accepted its application with Priority Review, targeting a decision by the end of February 2027. It's a once-daily oral candidate for EPP and XLP, rare disorders in which light exposure can trigger intense pain. LEO also closed its acquisition of worldwide rights from Tanabe.

The sponsor-reported Phase 3 INSPIRE trial measured average daily sunlight exposure before the first warning symptom. Over weeks twelve through sixteen, the improvement from baseline was about twenty-three minutes greater with dersimelagon than with placebo. That's a group-average treatment difference. It doesn't promise an individual patient twenty-three extra pain-free minutes each day.

Light avoidance can constrain work and school, which is why time outdoors matters here. What would a daily pill add to the treatment choices?

A different route. Scenesse is an implant approved in the U.S. for adults with EPP. Dersimelagon was studied in both EPP and XLP. INSPIRE compared the pill with placebo, not the implant, so it doesn't establish which treatment works better.

For LEO, the completed rights transfer brings a late-stage oral candidate into a business already focused on medical dermatology. The company gains a rare-disease program approaching an FDA decision; approval and the eventual label remain open.

That's where we'll leave it for Friday. Thanks for spending part of your day with us. Have a good weekend.

Follow the show on Apple Podcasts, Spotify, or wherever you listen — a quick rating or share helps other listeners find us. The Week in Review lands Sunday.