Top Stories
Merck Drops $6.7B on Terns to Secure CML Asset Ahead of Keytruda Cliff
Merck announced a $6.7 billion all-cash acquisition of Terns Pharmaceuticals, according to Fierce Biotech, adding the biotech's chronic myeloid leukemia program to its oncology pipeline as Keytruda faces patent expiration. The deal centers on TERN-701, Terns' allosteric BCR-ABL inhibitor that has shown promise in treating CML patients with resistance mutations, per European Pharmaceutical Review. The acquisition signals aggressive preparation for the Keytruda revenue cliff expected around 2028–2030. Terns shareholders receive immediate cash at a significant premium to recent trading levels. Merck secures differentiated CML asset with strong resistance profile. Smaller biotechs lose independent CML competitor as consolidation accelerates.
FDA Approves Corcept's Lifyorli for Platinum-Resistant Ovarian Cancer 3.5 Months Early
The FDA approved Lifyorli (relacorilant), a first-in-class selective glucocorticoid receptor antagonist, in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer on March 25, 2026 — 3.5 months ahead of the July 11, 2026 PDUFA date. Approval is based on the Phase 3 ROSELLA trial (N=381), which showed a 35% reduction in risk of death (OS HR 0.65; p=0.0004; median OS 16.0 vs 11.9 months) and a 30% reduction in risk of progression (PFS HR 0.70; p=0.008; median PFS 6.5 vs 5.5 months) versus nab-paclitaxel alone. Patients must have received one to three prior systemic regimens, including at least one containing bevacizumab. Corcept establishes a new treatment option in platinum-resistant ovarian cancer with a novel cortisol-modulating mechanism. Existing nab-paclitaxel monotherapy regimens lose ground as relacorilant combination becomes the preferred approach.
AstraZeneca's In Vivo CAR-T Shows Early Responses but One Death in China Myeloma Trial
Data published in Nature Medicine on March 27, 2026 from a Chinese Phase 1 trial of AstraZeneca's in vivo BCMA CAR-T candidate ESO-T01 showed four of five patients with multiply relapsed, refractory multiple myeloma achieved objective responses, including three stringent complete remissions by day 60, per Endpoints News. However, one patient died after a myeloma lesion outside the bone marrow compressed his spinal cord. AstraZeneca acquired the in vivo CAR-T platform by purchasing Belgium-based EsoBiotec in 2025 for $425 million upfront plus up to $575 million in milestones. The technology uses lentiviral vectors to generate CAR-T cells directly inside the patient's body, eliminating the need for external cell manufacturing. AstraZeneca validates in vivo CAR-T concept with early complete responses in heavily pretreated myeloma. The on-study death, though attributed to disease progression, casts a shadow over early safety data in a five-patient trial.
Novocure Reports Positive Phase 2 Data Extending TTFields to Metastatic Pancreatic Cancer
Novocure announced positive topline results on March 26, 2026 from the Phase 2 PANOVA-4 trial of Tumor Treating Fields (TTFields) combined with atezolizumab, gemcitabine, and nab-paclitaxel as first-line treatment for metastatic pancreatic ductal adenocarcinoma, per Business Wire. The trial met its primary endpoint with a disease control rate of 74.4% in the TTFields combination arm (N=78) versus 48% in the MPACT historical control (p<0.001). Objective response rate was 34.6% and median overall survival was 9.7 months. Following FDA approval of TTFields for locally advanced pancreatic cancer based on the Phase 3 PANOVA-3 trial earlier this year, Novocure is now extending the platform into the metastatic setting. Novocure expands its pancreatic cancer franchise into metastatic disease with a meaningful DCR improvement over historical control. The single-arm design with historical comparator will face scrutiny; a randomized Phase 3 trial may be required for regulatory approval in metastatic disease.
EMA Flags Baxter Ifosfamide Shortage Across EU Until Early 2027
The European Medicines Agency warned on March 24, 2026 that Baxter International's ifosfamide-containing cancer drugs will remain in shortage across the EU until the first quarter of 2027, per Reuters. The shortage stems from a technical disruption at Baxter's contract manufacturing site, compounded by site improvements required after a regulatory inspection in September 2025. Ifosfamide is used alone or in combination to treat testicular, small cell lung, and cervical cancers, and Baxter is the primary EU supplier. The EMA also flagged a separate shortage of Baxter's cyclophosphamide (Endoxan, Sendoxan, Genoxal) until early 2027 due to the same site disruption. Baxter has implemented quota-based distribution to manage existing inventory. Alternative ifosfamide suppliers may gain temporary EU market share during the shortage period. EU oncologists face treatment disruptions for ifosfamide-dependent regimens through at least Q1 2027.
Pipeline Watch
The FDA granted fast track designation to an undisclosed ALK inhibitor for treatment of ALK-positive non-small cell lung cancer, per CancerNetwork. The designation accelerates development of what could be a next-generation competitor to Pfizer's Lorbrena and Takeda's Alunbrig in the resistant ALK space.
Eli Lilly initiated the Phase 3 SUNRAY-02 trial evaluating olomorasib (LY3537982) in combination with standard-of-care immunotherapy in patients with resected or unresectable KRAS G12C-mutant NSCLC, per ClinicalTrials.gov. Olomorasib previously received FDA Breakthrough Therapy designation in first-line metastatic KRAS G12C NSCLC with PD-L1 ≥50% based on early data showing an ORR of 63% and DCR of 93%. This trial complements the ongoing SUNRAY-01 Phase 3 study in the metastatic setting. Lilly broadens olomorasib development into earlier-stage NSCLC, potentially ahead of Amgen's sotorasib and Mirati/BMS competitors.
Allogene Therapeutics is approaching an interim futility analysis in early Q2 2026 for its pivotal Phase 2 ALPHA3 trial of cemacabtagene ansegedleucel (cema-cel), an allogeneic CAR-T product, as first-line MRD-guided consolidation in large B-cell lymphoma, per Allogene press release and STAT. A primary EFS readout is expected in H2 2026, with a potential BLA submission targeted for 2027 if results are positive. [Note: STAT+ coverage is paywalled; Allogene press release used as primary source.]
A class-action lawsuit filed in U.S. District Court in New Jersey alleges Novartis used tracking pixels and cookies on branded drug websites including Kisqali's to share patients' health information with third parties such as Google and Contentsquare without consent, per Fierce Pharma and Bloomberg Law. The lead plaintiff, a breast cancer patient prescribed Kisqali, claims the data collection occurred when she visited the site to enroll in a savings program in late 2024. The class may include at least 100,000 US patients. The complaint also cites trackers on Pluvicto (prostate cancer radiotherapy) and other Novartis product websites.
An NCI-sponsored Phase 2 trial testing Triapine plus cisplatin with radiation therapy in advanced cervical and vaginal cancers remains active but not recruiting, per ClinicalTrials.gov. The study evaluates the ribonucleotide reductase inhibitor in combination with standard chemoradiation protocols.
Princess Margaret Cancer Centre's Lillian Siu highlighted emerging brain cancer therapeutics at the AACR special conference, per OncoDaily. The session focused on novel approaches crossing the blood-brain barrier and combination strategies for glioblastoma and brain metastases.
Competitive Landscape
Merck's $6.7B Terns buyout reflects broader Big Pharma urgency to secure differentiated hematology programs, per Fierce Biotech. Companies with rare blood cancer platforms command premium valuations. Independent hematology biotechs face accelerating acquisition pressure.
| Company | Recent CML Deal | Valuation Premium |
|---|---|---|
| Merck | Terns $6.7B | High |
| Bristol Myers | No Recent Deal | N/A |
| Novartis | Tasigna Generic | Declining |
Lifyorli's early approval creates a new standard in platinum-resistant ovarian cancer with OS HR 0.65, per Corcept and Business Wire. Corcept enters gynecologic oncology with a differentiated mechanism and strong survival data. Existing single-agent nab-paclitaxel, bevacizumab, and PARP inhibitor retreatment strategies face new competitive pressure.
AstraZeneca's ESO-T01 in vivo CAR-T and Allogene's cema-cel allogeneic CAR-T represent competing approaches to eliminate autologous manufacturing bottlenecks, per Endpoints News and Allogene Therapeutics. Both programs advancing toward pivotal data in 2026 could reshape the CAR-T manufacturing paradigm. Autologous CAR-T manufacturers (Novartis Kymriah, Gilead Yescarta, BMS Breyanzi) face long-term disruption risk if off-the-shelf approaches demonstrate comparable efficacy.
New ALK inhibitor fast track designation challenges Pfizer's Lorbrena dominance in resistant NSCLC, per CancerNetwork. Separately, Lilly's olomorasib KRAS G12C program expansion adds competitive pressure in the broader lung cancer targeted therapy landscape.
Forward Looking
- Watch for Merck integration timeline and TERN-701 Phase 3 trial design in CML-resistant patients. Regulatory filing timeline will clarify competitive positioning against Novartis's Scemblix.
- Corcept Lifyorli commercial launch expected in Q2 2026. Track uptake among gynecologic oncologists and payer coverage decisions for the relacorilant-nab-paclitaxel combination.
- Allogene ALPHA3 interim futility analysis in early Q2 2026 will be the first major test of allogeneic CAR-T in a randomized setting. Primary EFS readout expected H2 2026.
- AstraZeneca ESO-T01 in vivo CAR-T dose-escalation data from the ongoing Phase 1 trial expected through 2026. Larger cohort data needed to contextualize the on-study death.
- Novocure likely to design a randomized Phase 3 trial for TTFields in metastatic pancreatic cancer following PANOVA-4 results. Trial design announcement expected H2 2026.
- Monitor Baxter ifosfamide and cyclophosphamide supply recovery in the EU. EMA expects normalization no earlier than Q1 2027. Alternative supplier availability will determine treatment disruption severity.
- Eli Lilly olomorasib SUNRAY-01 and SUNRAY-02 Phase 3 enrollment updates expected at ASCO 2026. Breakthrough Therapy designation may accelerate regulatory path if data matures favorably.