Sam­sung Bioepis launch­es a Rem­i­cade knock­off at a 35% dis­count; FDA OK’s a self-ad­min­is­tered ver­sion of Benlysta

→ The South Ko­re­an biosim­i­lar play­er Sam­sung Bioepis has launched a copy­cat of Rem­i­cade on the US mar­ket at a 35% dis­count to J&J’s list price for that ther­a­py. Rem­i­cade is J&J’s top earn­er, and the phar­ma gi­ant has filed suit to try and stop Sam­sung’s ri­val for be­ing in­tro­duced. There’s been con­sid­er­able spec­u­la­tion on how gener­ic ver­sions of bi­o­log­ics could im­pact pric­ing.

→ The FDA ap­proved a sub­cu­ta­neous for­mu­la­tion of Benlysta for lu­pus, mak­ing it pos­si­ble for pa­tients to switch from an IV ver­sion of the GSK drug to a self-ad­min­is­tered shot.

→ Ox­ford-based e-Ther­a­peu­tics — which once tried to de­vel­op ex­tend­ed re­lease tra­madol as an an­ti­de­pres­sant — is punt­ing four pipeline projects, nar­row­ing its fo­cus to two pro­grams in im­muno-on­col­o­gy and stak­ing its fu­ture on build­ing a rep­u­ta­tion for com­put­er-dri­ven drug dis­cov­ery work.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Take­da ax­es gene ther­a­py deal with Po­sei­da Ther­a­peu­tics amid broad­er re­think

Less than two years after Takeda inked a collaboration with Poseida Therapeutics to develop six liver-directed and hematopoietic stem cell-directed in vivo gene therapies, Takeda will end the partnership on July 30, the company confirmed to Endpoints News.

The breakup is not unexpected, coming on the heels of Takeda’s April announcement that it planned to stop discovery and preclinical work in AAV gene therapy, as well as research and preclinical work on rare hematology. A representative for Takeda confirmed that the partnership ended because of the company’s decision to stop that work.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

As­traZeneca tri­al shows mod­est ben­e­fit in ovar­i­an can­cer, but doc­tors say it's hard to ap­ply find­ings: #AS­CO23

CHICAGO — Adding AstraZeneca’s Imfinzi and Lynparza to the treatment regimen for patients with advanced ovarian cancer and no BRCA mutation extended progression-free survival (PFS) by five months, according to interim data released at the ASCO annual meeting Saturday morning.

However, the design of the Phase III study obscures how much Imfinzi is contributing to the PFS extension, doctors said, making it difficult to apply the findings to clinical practice.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Keytru­da be­fore and af­ter lung can­cer surgery cuts re­lapse risk by 42%, but doesn’t im­prove sur­vival: #AS­CO23

CHICAGO — Merck has found partial success with its latest effort to more aggressively treat earlier stages of lung cancer.

On Saturday the pharma giant announced results from a large trial in which patients received Merck’s immunotherapy Keytruda plus chemotherapy before surgeons removed their tumors, followed by another course of Keytruda afterward.

The Phase III study, called KEYNOTE-671, enrolled 800 people with the early stages of the most common kind of lung cancer: non-small cell lung cancer, or NSCLC. Everyone got chemo before surgery, and half also got Keytruda before and after. At two years, 62.4% of those who got Keytruda kept their cancer at bay, compared to 40.6% who got a placebo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Grail’s blood test charts path for di­ag­nos­ing pa­tients sus­pect­ed of hav­ing can­cer in large study: #AS­CO23

Grail’s vision is simple but bold. The blood testing company has long held that people are often diagnosed with cancer too late. If seemingly healthy people were screened for early signs of the disease before symptoms appear, they may be able to get more effective treatments that nip cancer in the bud.

That premise is the basis of Grail’s commercial blood test, Galleri, which searches for the genetic fingerprints of cancer in the blood. The test, launched in 2021, reaped $55 million in sales last year, but now the company is setting its sights on a new market: patients suspected of having cancer due to symptoms such as abdominal pain, rectal bleeding or unexplained weight loss. Rather than administering expensive scans or conducting invasive biopsies right away, Grail hopes doctors will consider a simple blood test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.