Biotech & Longevity · Monday, 26 October 2026
Roche's pill divarasib beats two lung-cancer pills already on sale in a head-to-head final trial, and patients on it live longer
Half the patients on divarasib were alive at 17.7 months against 12 on Amgen's Lumakras or Bristol Myers Squibb's Krazati, as ESMO's top session also showed two pills beating chemotherapy after Tagrisso and a Chinese antibody beating Imfinzi.
17.7 vs 12.0
months until half the patients had died, on divarasib against the older pills
a 44% lower risk of death in 338 patients
58% vs 32%
of patients whose tumours shrank, divarasib against Lumakras or Krazati
the shrinking lasted a median 11.9 months against 6.9
4.8% vs 11.7%
of patients who stopped treatment because of side effects
serious side effects were about half as common, 7.8% against 15.2%
The lead story — what happened
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Roche's pill divarasib beat the two lung-cancer pills already on sale for the same faulty gene, in a final-stage trial shown on Sunday.
[1] [2] -
The results were shown in Madrid at ESMO, the yearly meeting of the European Society for Medical Oncology, a society of cancer doctors.
[2] -
The cancers carry KRAS G12C, a gene change that jams a growth switch in the 'on' position. About one in eight people with the most common lung cancer have it.
[1] -
The trial gave 338 people whose cancer had grown after earlier treatment either divarasib or an older pill: Amgen's Lumakras or Bristol Myers Squibb's Krazati.
[2] -
Half the patients on divarasib were still alive at 17.7 months, against 12 months on the older pills. Their risk of death was 44% lower.
[1] [2] -
Tumours shrank in 58% of patients on divarasib and 32% on the older pills. At one year, 44% against 24% were alive with no tumour growth.
[1] -
Fewer patients stopped divarasib because of side effects, 4.8% against 11.7%, even though they stayed on it more than twice as long.
[1] -
Roche said in July that the trial had met its goals, but held back the numbers until this meeting.
[2] -
Drugmakers rarely test against a rival's drug, Roche's deputy medical chief Stefan Frings told Fierce Biotech, but a head-to-head win helps convince payers, doctors and patients.
[2] -
Roche dropped a trial against docetaxel, an older chemotherapy, to run this one against the two pills instead.
[2] -
The older pills sell little: Krazati brought in $55 million and Lumakras $111 million in the second quarter. Roche hopes divarasib will reach 1 to 2 billion Swiss francs a year at its peak.
[2] -
Patients and doctors knew which pill each person was taking, because the trial was not blinded.
[1]
Who is involved
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Roche
a big Swiss drugmaker; it made divarasib and ran the trial
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Amgen
a large US drugmaker; its Lumakras was the first pill approved for this gene change, in 2021
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Bristol Myers Squibb
a large US drugmaker; its Krazati was approved in 2022
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Ferdinandos Skoulidis
a lung cancer doctor at MD Anderson Cancer Center in Texas; the study's lead author
How it unfolded
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2021 Amgen's Lumakras reaches the market first for this gene change
[2] -
2022 Bristol Myers Squibb's Krazati follows, and the FDA, the US drug regulator, puts divarasib on a faster review path
[1] [2] -
July 2026 Roche says the trial met its goals but keeps the numbers back
[2] -
25 Oct Full results are shown at ESMO in Madrid
[1] [2]
Where this points
Roche has not said when it will ask regulators to approve divarasib; its next test is Krascendo 2, which pairs it with Merck's Keytruda as a first treatment against Keytruda with chemotherapy.
Signals on this beat
The bar and the word are our reading of how hard each one is pushing, and the arrow is where it is heading.
Divarasib beat the older pills in people whose cancer had grown after earlier treatment.
Akeso, a Chinese drugmaker, ran its winning bile duct cancer trial in China alone.
AstraZeneca's sone-ve doubled median survival in stomach cancer patients who had had two earlier treatments, while missing its goal on tumour growth.
Attackers killed a nurse answering an Ebola alert in Congo, where more than 4,700 people have died since May.
The rest of the day
13 more stories on this beat.
Each with its own sources. None of these is a link to the story above.
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02
Two pills beat chemotherapy after Tagrisso fails
AstraZeneca and HUTCHMED showed full results of SAFFRON, a final-stage trial, at ESMO on Sunday, and the New England Journal of Medicine, a leading medical journal, published them the same day.
[3] [4] Tagrisso is AstraZeneca's pill for lung cancers driven by a faulty EGFR gene, and many of these cancers later escape it by turning up a second growth signal, MET.[3] In 338 patients with high MET, adding HUTCHMED's MET-blocking pill savolitinib to Tagrisso kept 70% alive at one year, against 53% on chemotherapy.[3] Half were alive at 17.8 months, against 12.9.[3] [4] Tagrisso plus savolitinib70%Chemotherapy53%Share of patients still alive one year into the SAFFRON trial. Why it matters — About a third of patients whose cancer escapes Tagrisso do so through high MET, said the trial's lead doctor, Shun Lu of Shanghai Chest Hospital.
[3] The pair is already approved in China, and AstraZeneca has asked the US regulator to approve it as an all-pill treatment instead of chemotherapy.[3] -
03
A Chinese antibody beats Imfinzi in bile duct cancer
Akeso, a Chinese drugmaker, said its antibody ivonescimab with chemotherapy helped people with advanced biliary tract cancer live longer than AstraZeneca's Imfinzi with chemotherapy, the standard first treatment.
[5] [6] These cancers start in the bile ducts or the gallbladder, and fewer than 5% of people whose cancer has spread live five years.[6] Ivonescimab is one antibody that does two jobs: it frees the immune system and stops tumours growing new blood vessels.[5] In 682 patients in China, half were alive at 14.9 months, against 12.1 on Imfinzi.[5] [6] Ivonescimab44%Imfinzi32.5%Share of patients still alive at 18 months in the HARMONi-GI1 trial. Why it matters — At 18 months, 44% were alive on ivonescimab against 32.5% on Imfinzi, and the result was shown in ESMO's top session.
[5] The trial ran only in China, and Summit Therapeutics, a US company that holds the drug's rights in its own territories, notes it is not approved there.[6] -
04
AstraZeneca's stomach cancer drug doubles survival
AstraZeneca showed full results for sone-ve, an antibody joined to a cell-killing poison, in advanced cancer of the stomach and food pipe.
[7] [8] The antibody seeks out claudin 18.2, a protein found on many of these cancer cells.[8] Patients who had already had two treatments lived a median 10 months on sone-ve, against 5 months on chemotherapy, and 10.6 against 6.4 across the whole trial.[7] [8] The time before tumours grew, judged by reviewers who did not know the treatment, was 4.2 months against 3.8, too close to count as a win.[7] 10 monthsSone-ve5 monthsChemotherapyMedian survival in patients who had already had two treatments. Tumour growth was barely slowed, yet people lived about twice as long. Why it matters — AstraZeneca says the data are strong enough to take to regulators, and four of the 12 presentations in ESMO's top sessions featured its medicines.
[7] [9] The trial took patients with the protein on at least 25% of tumour cells, against 75% for the approved drug on this target, which AstraZeneca says could double who qualifies.[8] -
05
A nurse is killed at an Ebola alert in Congo
Attackers killed a nurse and badly injured another health worker on Saturday in Bafwasende, a town in Congo's Tshopo province, as they answered an Ebola alert, the World Health Organization said.
[16] Congo's health ministry counts more than 9,800 cases and more than 4,700 deaths since May, the deadliest Ebola outbreak in the country's history.[16] Responders say distrust of how Congo's government has handled the outbreak makes their work harder, and some people call Ebola a hoax.[16] In September a politician who defended the response was beaten to death in North Kivu.[16] Why it matters — The Bundibugyo kind of Ebola behind this outbreak has no approved vaccine or specific treatment.
[16] Local officials have not said who carried out the attack, and the WHO's Africa director said fear and false claims must never fuel violence.[16] -
06
Uganda makes returnees from Congo pay for quarantine
Uganda said on Sunday that citizens returning from Congo must spend 21 days in quarantine at their own expense.
[17] Congolese travellers on non-essential trips will be sent back at their own cost, and screening is tighter at Entebbe airport and land borders.[17] Uganda declared its own outbreak over on 28 July and reports no active cases.[17] [18] But the first Ebola patients in Kenya and Nigeria both passed through Entebbe airport on 3 October, the Africa CDC says.[18] Why it matters — On 23 October the WHO advised against limits on travel or trade with affected countries, so Uganda's rule goes further than that advice.
[16] Kenya is still trying to reach a Ugandan man listed as a contact of its first patient, Kenya's Daily Nation reported.[18] -
07
Most cancer drugs approved in Europe score low
A new analysis found that only 31% of 97 cancer uses approved in Europe from January 2022 to July 2026 offered a high benefit to patients, STAT reported on Friday.
[15] It graded them with a scale from ESMO, the European cancer doctors' society, which rates how much a drug helps.[15] Of 63 cancer drugs, 19 had at least one high-benefit use, and nine reached the top grade.[15] Five drugmakers made more than half of the 30 high-benefit uses.[15] Why it matters — Four of those five companies are based in China or Japan, which the researchers called a fundamental shift in where cancer medicines come from.
[15] Two of Sunday's results, from Akeso and Innovent, come from Chinese drugmakers. -
08
BioNTech and BMS show early results after immunotherapy
BioNTech and Bristol Myers Squibb showed first results for pumitamig, an antibody that blocks two targets at once, in lung cancer that had grown after immunotherapy and chemotherapy.
[10] [11] Given with docetaxel, an older chemotherapy, it shrank tumours in 36.7% of 30 patients who could be assessed.[10] Half of all 50 patients went 6.9 months before their cancer grew, against about 3.6 to 3.9 months for docetaxel alone in past studies.[10] Every patient got the pair, so there was no docetaxel-only group to compare.[10] Why it matters — BioNTech bought Biotheus, the Chinese company that made pumitamig, for over $800 million, and Bristol Myers Squibb joined in a deal worth up to $11.1 billion.
[11] BioNTech said on Thursday it will also test pumitamig with Gilead's breast cancer drug Trodelvy in a final-stage trial.[12] -
09
Innovent's two-in-one immune drug shows early results
Innovent Biologics, a Chinese drugmaker, showed updated early results at ESMO for IBI363, one protein that releases an immune brake called PD-1 and also carries IL-2, a signal that makes immune cells multiply.
[13] It was given with chemotherapy to 69 people with untreated lung cancer low in PD-L1, a marker on tumours; immune drugs tend to work less well when it is low.[13] Tumours shrank in 47.4% to 86.4% of patients, depending on which of three dose groups they were in.[13] Why it matters — How long patients live without tumour growth is not yet known, and a trial against Merck's Keytruda with chemotherapy is now running.
[13] Takeda, a Japanese drugmaker, paid $1.2 billion up front a year ago for the rights outside China to this drug and a second one.[14] -
10
Blocking a tumour signal helps an immune drug
A small trial at four hospitals in Italy found that adding an antibody called visugromab to the immune drug nivolumab before surgery cleared more bladder tumours, Nature Medicine reported on Saturday.
[20] Visugromab blocks GDF-15, a signal that bladder tumours make in large amounts and that may stop immune drugs working.[20] No cancer was left at surgery in 5 of 15 patients on the pair, against 1 of 13 on nivolumab and a dummy drug.[20] The 31 patients could not have or refused cisplatin, the usual chemotherapy.[20] Nivolumab plus visugromab33%Nivolumab plus dummy8%Share of patients with no cancer left at surgery. The groups were 15 and 13 people. Why it matters — Patients were not assigned to the groups at random and the trial was small, so it points to a bigger test rather than proving the pair works.
[20] -
11
Biotech shares and share sales bounce back
The biggest biotech stock fund, iShares Biotechnology, rose 34% in the 12 months to Friday, and State Street's SPDR S&P Biotech fund rose 39%.
[19] Biotech companies raised about $7.8 billion selling shares to the public for the first time this year, against $1.2 billion in all of 2025, according to the investment bank Locust Walk.[19] But licensing deals, where one company buys rights to another's drug, fell to a two-year low of about $48 billion in the third quarter.[19] 2026 so far$7.80bnAll of 2025$1.20bnMoney biotech companies raised by listing their shares on a stock market for the first time. Why it matters — Chinese companies supplied 58% of this year's licensing value, up from 48% a year earlier, against 26% from the US and 8% from Europe and the UK.
[19] Locust Walk's chief, Geoff Meyerson, says this is because share sales in Hong Kong have become much harder and Chinese biotechs are almost never bought outright.[19] -
12
Treated blood calms immune drug side effects
Immune drugs for cancer sometimes make the immune system attack the gut, liver or skin, and steroids do not always stop it.
[21] A trial of 30 such patients, published in Nature Communications on Friday, tested photopheresis, in which blood is drawn, its white cells are treated with light and returned.[21] The side effects eased in 96.3% of cases, and the treatment caused no serious harm.[21] Every gut and skin case responded, and 13 of 15 liver cases did.[21] Why it matters — Severe side effects force patients to pause a cancer drug that may be working and take drugs that dampen the immune system.
[21] The trial had no comparison group, so it shows the method is safe and promising, not that it beats other options.[21] -
13
Pancreatic tumours hold groups with different DNA
Scientists at NYU Langone Health, a New York hospital, read nearly half a million single pancreatic cancer cells and found that each tumour holds several groups of cells with different DNA changes.
[22] Some groups resist treatment and others spread more readily, the study in Nature Genetics on 13 October found.[22] A gene called MYC was most active in the most aggressive cells, and blocking it in lab cells turned them back to a milder kind.[22] Why it matters — Nearly 85% of people with this cancer die within five years, and these shifting groups help explain why it so often stops responding to treatment.
[22] The MYC result comes from cells in a dish, not from people.[22] -
14
Cancer doctors worry about doubts over mRNA
At ESMO on Saturday, Toni Choueiri of the Dana-Farber Cancer Institute, a Boston cancer hospital, said mistrust and false claims are a key challenge for any medicine made with mRNA.
[23] He cited a 2022 survey in which 15% of people wrongly believed the mRNA Covid shots could change human DNA.[23] Some now call Merck and Moderna's melanoma treatment a personalised neoantigen therapy instead of a vaccine.[23] Full results of its trial will be published next month in the New England Journal of Medicine.[23] Why it matters — The US government is backing cancer vaccines while it has sharply cut funding for mRNA vaccine research, STAT notes.
[23] Moderna's chief, Stephane Bancel, says success against cancer will change how people see mRNA.[23]
Why Chinese drugmakers sell the overseas rights to their best medicines
When selling shares in Hong Kong is hard and buyers rarely take over a Chinese biotech, selling a drug's rights abroad is how its maker raises cash.
The twist
A Chinese drugmaker sells a drug's rights outside China because it cannot easily raise money any other way. The buyer brings what the seller lacks: cash now, and the trials and sales teams to reach patients in other countries.
The picture
How it works
- A Chinese drugmaker finds a promising medicine
- Final trials and launches abroad need far more money than it has
- Selling new shares in Hong Kong has become much harder
- Buyers almost never take over a whole Chinese biotech
- So it sells the drug's rights outside China to a richer drugmaker
- The buyer pays cash up front and runs the trials and sales in other countries
The same force, elsewhere today
Where this chain is also running, in today's other stories.
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A Chinese antibody beats Imfinzi in bile duct cancer
Akeso ran its trial in China, while Summit, a US company, holds the drug's rights in its own territories, and AstraZeneca has agreed to invest $2 billion in Summit.
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BioNTech and BMS show early results after immunotherapy
Biotheus, the Chinese maker of pumitamig, was sold to BioNTech for over $800 million, and Bristol Myers Squibb then joined in a deal worth up to $11.1 billion; the partners now run seven final trials.
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Innovent's two-in-one immune drug shows early results
Innovent took $1.2 billion up front from Takeda for the rights outside China to two drugs, and the two companies now develop IBI363 together around the world.
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Two pills beat chemotherapy after Tagrisso fails
HUTCHMED made savolitinib, and its partner AstraZeneca ran the trial across many countries and asked the US regulator to approve the pair.
Where you've seen this
Independent films
a small studio sells the rights to show its film in other countries before filming, to pay for making it
Book publishing
an author's agent sells the right to translate a book, country by country, to publishers who already have shops there
Small farms
a grower with no shop sells the whole crop to a supermarket chain that has the lorries and the customers
The catch
This only holds while the other ways to raise money stay shut. If Hong Kong share sales reopen, or either government limits these deals, Chinese drugmakers would have to find their money elsewhere.
And the whole of it
A patient in Madrid or Michigan who gets one of these drugs depends on a trial run in China and a deal signed in another country. Behind both is a stock market in Hong Kong where these companies now find it hard to raise money. The patient and the doctor writing the prescription see none of this.
What is really going on
At Europe's biggest cancer meeting on Sunday, new drugs beat ones already on sale: Roche's divarasib beat Amgen's and Bristol Myers Squibb's pills, and Akeso's ivonescimab, invented in China, beat AstraZeneca's Imfinzi.
Why it works on us — Most of Sunday's cancer numbers reached the world through the drugmakers' own press releases on the day each result was shown, so the first account of each result is the company's own.
Who gains
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Roche
— A win against the two pills already on sale gives it the comparison payers and doctors ask for, and it hopes for 1 to 2 billion Swiss francs a year.
[2] -
Akeso and Summit Therapeutics
— Beating the standard treatment on survival lets them argue for ivonescimab beyond lung cancer, its first win in a gut cancer.
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HUTCHMED
— Its pill savolitinib now has a trial across many countries and an application with the US regulator, run by its partner AstraZeneca.
[3] [4] -
Chinese drugmakers that sell rights abroad
— Takeda paid Innovent $1.2 billion up front for rights outside China to two drugs.
[14] Chinese companies supplied 58% of this year's licensing value.[19] -
Biotech companies listing their shares
— They raised about $7.8 billion this year, against $1.2 billion in 2025.
[19]
Who pays
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Amgen and Bristol Myers Squibb
— Their pills lost a head-to-head trial; they brought in only $111 million and $55 million in the second quarter.
[2] -
AstraZeneca, as maker of Imfinzi
— Its drug was the treatment beaten in the bile duct cancer trial.
[5] -
Health workers in Congo's Ebola zones
— A nurse was killed and another hurt while answering an alert.
[16] -
Ugandans coming home from Congo
— They must now pay for 21 days of quarantine themselves.
[17] -
Young biotech companies with early science
— Money for drugs not yet in people is still hard to raise, Locust Walk says.
[19]
What nobody knows yet
Open questions from across today’s stories — ours included.
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01
When divarasib could reach patients.
Roche's deputy medical chief would not give a date for asking regulators to approve it.
[2] Patients and doctors also knew which pill each person took, because the trial was not blinded.[1] -
02
How many patients AstraZeneca's sone-ve trial enrolled.
Fierce Biotech says the trial enrolled 594 patients, while Reuters calls it a 532-patient study.
[7] [8] Neither report explains the gap, and we could not settle it. -
03
Whether regulators will approve sone-ve after it missed its tumour-growth goal.
AstraZeneca says the survival gain is strong enough to file.
[7] HSBC analysts say the miss makes it harder to compare with Takeda and Innovent's rival drug.[8] -
04
Whether ivonescimab's bile duct result holds for patients outside China.
The trial ran only in China, and the drug is not approved where Summit holds its rights.
[6] -
05
Whether pumitamig with docetaxel beats docetaxel alone.
Every patient got the pair, so the 6.9 months is compared with older trials, not with a group inside this one.
[10] -
06
Where Nigeria's Ebola patient was infected.
Uganda's health ministry says she travelled to eastern Congo, but Switzerland says she and her husband did not go there.
[18] Uganda says its investigators have not settled it.[17] -
07
Where Kenya's missing Ebola contact is.
Kenya knows the Ugandan man's name and passport number but cannot reach him, and he used a South Sudanese phone number.
[18] -
08
Who attacked the health workers in Bafwasende.
Local authorities had not commented on the attack or the suspects.
[16] -
09
Whether blocking MYC helps people with pancreatic cancer.
The milder cells were seen only in a dish.
[22]
Half the people given Roche's divarasib were still alive at 17.7 months, against 12 months on the older pills, and fewer of them had to stop treatment because of side effects.
Also true today
- All 60 people in Uganda who had been in contact with Kenya's first Ebola patient finished 21 days of checks with no symptoms.
- In the SAFFRON trial, 70 in 100 people taking Tagrisso with savolitinib were alive after a year, against 53 in 100 on chemotherapy.
- In a trial of 30 cancer patients whose immune drugs had turned their immune systems against their own bodies, treated blood eased the damage in 96.3% of cases.
- At 18 months, 44 in 100 people with advanced bile duct cancer on ivonescimab were alive, against 32.5 in 100 on the standard treatment.
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